Exhibit 10.33
 
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY
WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE
ACT OF 1934.
 
COLLABORATION AND LICENSE AGREEMENT
 
This Collaboration and License Agreement (the “Agreement”) is entered into as of
11 December 2014 (the “Effective Date”), by and between Anthera Pharmaceuticals,
Inc., a corporation organized under the laws of the State of Delaware, USA
(“ANTHERA”), having an address of 25801 Industrial Blvd., Suite B, Hayward, CA
94545, USA, and Zenyaku Kogyo Co., Ltd., a corporation existing and organized
under the laws of Japan, having its registered offices at 5-6-15, Otsuka,
Bunkyo-ku, Tokyo, Japan 1128650 (“ZENYAKU”).
 

Recitals
 
Whereas, ANTHERA owns or has licensed certain patent rights, know-how and other
intellectual property relating to Blisibimod (also referred to as A-623 and/or
AMG-623), an anti-BAFF (B cell activating factor) peptibody: [***];
 
Whereas, ZENYAKU is engaged in the research, development and commercialization
of pharmaceutical products;
 
Whereas, ZENYAKU desires to obtain from ANTHERA, and ANTHERA is willing to grant
to ZENYAKU, an exclusive license to develop and commercialize Product in the
Field in the ZENYAKU Territory (each as hereinafter defined), on the terms and
subject to the conditions set forth in this Agreement;
 
Whereas, ANTHERA is conducting, and plans to conduct in the future, Phase 3
clinical trials and such other development activities with respect to Product as
are necessary to complete and submit to the U.S. Food and Drug Administration a
Biologics License Application for Product in the United States of America; and
 
Whereas, ZENYAKU desires to conduct, in the future, Phase 3 clinical trials and
such other development activities with respect to Product as are necessary to
complete and submit to the Regulatory Authority (as defined below) in Japan a
request for Regulatory Approval (as defined below) for Blisibimod for the
Initial Indication (defined below) and potentially other indications; and
 
Whereas, the parties desire to collaborate in those development and registration
activities with respect to Product in the United States of America and Japan
(and potentially other countries in the Option Territory (as hereinafter
defined)) as are necessary for registration of Product in countries of the
ZENYAKU Territory, in each case, on the terms and subject to the conditions set
forth in this Agreement;
 
Now, Therefore, in consideration of the foregoing premises and the mutual
covenants contained herein and other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, the parties agree as
follows.
 
1.
Definitions

 
1.1            “Affiliate” shall mean any legal entity controlled by,
controlling, or under common control with a party hereto.  For the purpose of
this definition, a legal entity shall be deemed to “control” another entity, if
it owns directly or indirectly, 50% or more of the outstanding voting
securities, capital stock, or other comparable equity or ownership interest of
such entity, or exercises equivalent influence over such entity.
 
1.2           “Amgen” shall mean Amgen Inc., a Delaware corporation.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
 

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1.3           “Amgen Agreement” shall mean that certain License Agreement dated
December 18, 2007 between ANTHERA and Amgen, as amended October 16, 2009 and
November 26th, 2014, and as the same may be amended from time to time in
accordance with this Agreement.  The Amgen Agreement (including all amendments
through the Effective Date) is set forth in Exhibit A.
 
1.4           “Amgen Royalty” shall mean any and all sales royalties due to
Amgen on sales of Compound and/or Product by or under right from ZENYAKU in the
ZENYAKU Territory pursuant to the Amgen Agreement, not to exceed the [***]
percent ([***]), subject to any royalty reductions permitted pursuant to the
terms of the Amgen Agreement.
 
1.5           “Amgen Royalty Term” shall mean [***].
 
1.6           “Amgen Patents” shall mean all Patents licensed to ANTHERA under
the Amgen Agreement.
 
1.7           “ANTHERA Development Plan” means ANTHERA’s written plan for any
Compound and Product development activities that ANTHERA will undertake, if any,
beyond and [***] set forth in the Joint Development Plan.  References to the
ANTHERA Development Plan refer to the then-current version.
 
1.8           “ANTHERA FTE Rate” shall mean [***] U.S. dollars [***] per FTE per
year.
 
1.9           “ANTHERA Invention” shall mean any Invention made by one or more
employees or contractors (or personnel of contractors) of ANTHERA or its
Affiliate, and no employees or contractors (or personnel of contractors) of
ZENYAKU.  ANTHERA Inventions may be made together by one or more employees or
contractors (or personnel of contractors) of ANTHERA or its Affiliate, and any
Third Party, including any Other Licensee, and in that case the applicable
ANTHERA Invention is only to the extent of ANTHERA’s or its Affiliate’s
ownership interest in the applicable Invention (recognizing that ANTHERA or its
Affiliate may hold only an undivided interest in such Invention).
 
1.10           “ANTHERA Know-How” shall mean any and all Product Know-How that
ANTHERA or its Affiliate (subject to Section 16.5) Controls as of the Effective
Date or during the Term and that is necessary or useful to develop, obtain
Regulatory Approval for, use, manufacture or commercialize Compound and Product
in the Field in the ZENYAKU Territory, including without limitation ANTHERA
Inventions.  For clarity, ANTHERA Know-How shall exclude Joint Inventions and
any rights under ANTHERA Patents.
 
1.11           “ANTHERA Patents” shall mean all Patents Controlled by ANTHERA or
its Affiliates (subject to Section 16.5) as of the Effective Date or during the
Term that Cover any Compound or Product in the Field in the ZENYAKU Territory,
including all Amgen Patents within the ZENYAKU Territory. The ANTHERA Patents as
of the Effective Date are set forth in Exhibit B, with those that are Amgen
Patents clearly identified. For the avoidance of doubt, ANTHERA Patents exclude
claims of Patents Controlled by ANTHERA that are directed to any therapeutically
active ingredient other than Compound or Product.
 
1.12           “ANTHERA Technology” shall mean the ANTHERA Know-How and ANTHERA
Patents, including ANTHERA’s interest in Joint Inventions and Joint Patents.
 
1.13           “ANTHERA Territory” shall mean the entire world, excluding the
ZENYAKU Territory.  For clarity, the ANTHERA Territory shall include the Option
Territory unless and until ZENYAKU exercise the ZENYAKU Option.
 
1.14           “BAFF” means B cell activating factor.
 
1.15           “B.L.A.” shall mean a Biologics License Application as set forth
in 21 C.F.R 600 – 680 or its equivalent in a country other than the US.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
2.

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1.16            “Blisibimod” shall mean the composition set forth in Exhibit F,
which is also referred to as A-623 and/or AMG-623, and is an anti-BAFF
peptibody, [***]
 
1.17           “C.F.R.” shall mean the United States Code of Federal
Regulations.
 
1.18           “cGCP” shall mean current good clinical practices, as set forth
in 21 C.F.R. Parts 50, 54, 56, 312 and 314 and as interpreted by relevant ICH
guidelines; in each case, as amended from time to time.
 
1.19           “cGLP” shall mean current good laboratory practices, as set forth
in 21 C.F.R. Part 58 and as interpreted by relevant ICH guidelines; in each
case, as amended from time to time.
 
1.20           “cGMP” shall mean the current good manufacturing practices and
standards for the production of drugs and finished pharmaceuticals, as set forth
in 21 C.F.R. §§ 210 and 211 and as interpreted by relevant ICH guidelines; in
each case, as amended from time to time.
 
1.21           “CHABLIS-SC1 Study” shall mean the Phase 3 Trial as outlined in
Protocol No. CHABLIS-SC-1: AN-SLE3331, as may be amended from time to time.
 
1.22           “CHABLIS-SC2 Study” shall mean the Phase 3 Trial as outlined in
Protocol No. CHABLIS-SC-2:  AN-SLE3332, as may be amended from time to time.
 
1.23           “CMC” shall mean chemistry, manufacturing and controls
information required as part of a U.S. B.L.A.
 
1.24           “Combination Product” shall mean [***].
 
1.25           “Commercially Reasonable Efforts” shall mean:
 
(a)                   with respect to ZENYAKU’s obligations under this Agreement
to develop and commercialize Product in the Field in the ZENYAKU Territory, the
level of efforts required to carry out such obligations in a manner consistent
with the exercise of prudent scientific and business judgment [***].
Commercially Reasonable Efforts shall be determined on [***] basis and it is
anticipated that the level of effort constituting Commercially Reasonable
Efforts [***].
 
(b)                   with respect to ANTHERA’s obligations under this Agreement
to perform Joint Development Plan activities, the level of efforts required to
carry out such obligations in a manner consistent with the efforts that
biopharmaceutical companies typically devote to compounds of similar market
potential, resulting from their own research efforts, at a similar stage in
their development or product life.  As used herein, “biopharmaceutical
companies” means companies in the biopharmaceutical industry of a size and stage
of clinical development similar to that of ANTHERA, including having human
pharmaceutical compounds in a similar stage of development to Compound.
 
1.26           “Competing Product” means, other than a Compound or Product, any
pharmaceutical product containing or comprising a compound or other composition
(including peptides, peptibodies, antibodies, and other biologics) that [***]  .
 
1.27           “Compound” shall mean Blisibimod and [***].
 
1.28           “Confidential Information” shall have the meaning provided in
Article 12.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
3.

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1.29           “Control” shall mean, with respect to any Information, Patents or
other intellectual property rights, possession by a party of the right, power
and authority (whether by ownership, license or otherwise) to grant access to,
to grant use of, or to grant a license or a sublicense to such Information,
Patents or intellectual property rights without violating the terms of any
agreement or other arrangement with any Third Party, or being obligated to pay
any royalties or other consideration therefor, in existence as of the time such
Party (or its Affiliates) would first be required hereunder to grant the other
Party such license or access.  Notwithstanding the foregoing, with respect to
any material, Patent, Information, Regulatory Approvals or [***].  Nothing in
this definition of “Control” shall be read to diminish a Party’s obligation to
use Commercially Reasonable Efforts to obtain the applicable grant-back license
provided for in this Agreement [***] (as applicable).
 
1.30           “Cost of Goods” shall mean:
 
(a)                   in the case of bulk or finished Compound or  Product
manufactured by ANTHERA, the actual fully-allocated cost of manufacturing such
Product (in accordance with cGMPs, if applicable) determined in accordance with
U.S. GAAP or IFRS (as applicable), consistently applied, [***]; or
 
(b)                   in the case of bulk or finished Product supplied by a
Third Party, Cost of Goods described in clause (a) shall consist of: (i) the
amount [***], including the [***]  .
 
1.31           “Cover” means, with respect to a particular product, process or
use and a particular Patent, that in the absence of a license granted under, or
ownership of, such Patent (a) a claim of such Patent would be infringed by the
manufacture, use, offer for sale, sale or importation of such product, process
or use, and (b) a pending claim of such Patent would be infringed by the
manufacture, use, offer for sale, sale or importation of such product, process
or use if such pending claim were to issue in an issued patent.
 
1.32           “Data” shall mean any and all results of research, preclinical
studies, including in vitro and in vivo studies, clinical trials and other
testing of any Compound or Product conducted by or on behalf of a Party (or its
Affiliates or Sublicensees) either before or during the Term, and any and all
other data generated by or on behalf of a Party (or its Affiliates or
Sublicensees) related to the development, manufacture or commercialization of
any Compound or Product, including biological, chemical, pharmacological,
toxicological, pharmacokinetic, pharmacodynamic, clinical, CMC, analytical,
quality control, and other data, results and descriptions.
 
1.33           “Dollar” means a U.S. dollar, and “$” shall be interpreted
accordingly.
 
1.34           “DMF” means a Drug Master File, containing CMC information, or
equivalent outside the U.S.
 
1.35           “Drug Company” shall mean the Third Party counterparty to an
Industry Transaction.
 
1.36           “FDA” shall mean the United States Food and Drug Administration,
or any successor agency thereto in the U.S., or, if the context so indicates,
the equivalent Regulatory Authority in a country other than the U.S.
 
1.37           “Field” shall mean [***].
 
1.38           “First Commercial Sale” shall mean the first sale to a Third
Party or end-user Affiliate of ZENYAKU of a Product by ZENYAKU, its Affiliate or
Sublicensee.
 
1.39           “Follow-On Indication” shall mean [***].
 
1.40           “FTE” means the equivalent of the efforts of one person with the
appropriate expertise working full-time for one 12 month period [***].
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
4.

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1.41           “Generic Product” means, with respect to a given Product in a
given country in the ZENYAKU Territory, a product sold in such country by a
Third Party (other than a Sublicensee of ZENYAKU or any other Third Party
authorized to sell such product by ZENYAKU or a ZENYAKU Sublicensee) that (a)
contains the same active ingredient as the Product, and (b) is approved or
registered for use in such country pursuant to any drug approval process based
on (A) (x) reference to a Regulatory Approval for such Product held by ZENYAKU
or a ZENYAKU Affiliate or Sublicensee in such country or in another country,
and/or (y) reference to other publicly available clinical data with respect to
such Product generated by ZENYAKU or a ZENYAKU Affiliate or Sublicensee, and (B)
a demonstration of bioequivalence or similarity to such Product.
 
1.42           “Joint Development Plan” or “JDP” shall have the meaning provided
in Article 4. The Initial Joint Development Plan is attached hereto as Exhibit
C.
 
1.43           “ICH” shall mean the International Conference on Harmonization of
Technical Requirements for Registration of Pharmaceuticals for Human Use.
 
1.44           “IFRS” shall mean International Financial Reporting Standards, as
they exist from time to time, consistently applied.
 
1.45           “Indication” shall mean any indication for which a Product may be
developed or approved.
 
1.46           “Industry Transaction” shall have the meaning as to each Party as
given in Section 2.2.
 
1.47           “Information” shall mean all tangible and intangible
(a) information, techniques, technology, practices, trade secrets, inventions
(whether patentable or not), methods (including any analytical methods and other
quality control and assurance methods), processes, procedures, knowledge,
know-how, skill, experience, Data, results (including pharmacological,
toxicological and clinical test data and results), analytical and quality
control data or descriptions, software and algorithms and (b) compositions of
matter, cells, cell lines, assays, animal models and physical, biological or
chemical material.
 
1.48           “Initial Indication” shall mean Immunoglobulin A Nephropathies
(“IgAN”).
 
1.49           “Invention” shall mean any invention, whether or not patentable,
made in the course and as a result of the conduct of the activities expressly
contemplated by this Agreement during the Term, including any invention made in
the course of the activities under the Product Supply Agreement (if any).
 
1.50            “JDC” shall have the meaning provided in Article 4.
 
1.51            “Joint Invention” shall mean any Invention made jointly by one
or more employees or contractors (or personnel of contractors) of ANTHERA or its
Affiliate and one or more employees or contractors (or personnel of contractors)
of ZENYAKU or its Affiliate.  Third Parties may additionally be inventors of
Joint Inventions but the definition of Joint Invention will only refer to the
applicable invention to the extent of the ownership interest therein of a Party
or its Affiliate.
 
1.52           “Joint Patent” shall mean any Patent that claims a Joint
Invention.
 
1.53           “License” shall have the meaning provided in Section 2.1.
 
1.54           Manufacturing License” shall have the meaning provided in Section
2.1.

1.55           “Net Sales” shall mean the gross amounts invoiced by ZENYAKU, its
Affiliates and its Sublicensees on sales of Products (excluding sales to
Affiliates and Sublicensees who are not end users; provided, however, that
subsequent sales of Products by such Affiliates and Sublicensees shall be deemed
Net Sales for purposes of this Agreement), less the following deductions
specifically allocated to the Products and calculated in accordance with GAAP:
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
5.

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(a)                   [***]
 
(b)                   [***];
 
(c)                   [***];
 
(d)                   [***]; and
 
(e)                   [***].
 
It is understood by the Parties that no deductions shall be taken [***] related
to the Products incurred by ZENYAKU, its Affiliates or sublicensees.
 
With respect to end uses or services by ZENYAKU and its Affiliates themselves
using the Product for commercial purposes, the “Net Sales” for the purpose of
determining the royalty due for such Product shall be determined by taking the
average of the Net Sales paid by Third Parties in arms-length transactions with
ZENYAKU, its Affiliates or sublicensees during the period in question, or if no
such sales shall have occurred, the fair market value of the Licensed Product.
 
With respect to any Combination Product sold by ZENYAKU, its Affiliates or its
sublicensees, the “Net Sales” for the purpose of determining the royalty due for
such Combination Product shall be determined by [***].
 
1.56           “Option Territory” shall mean China (including Hong Kong),
Singapore, Taiwan, Philippines, Thailand, Malaysia, Vietnam, Indonesia, and
South Korea.
 
1.57           “Other License” means the agreement between ANTHERA  and its
Other Licensee by which such Other Licensee obtains rights under ANTHERA
Technology to Compound(s) and/or Product(s) anywhere in the ANTHERA Territory.
 
1.58           “Other Licensee” means any Third Party granted rights under
ANTHERA Technology by ANTHERA or its Affiliate to Compound(s) and/or Product(s)
anywhere in the ANTHERA Territory.
 
1.59           “Option Notice” has the meaning set forth in Section 2.2.
 
1.60           “Ownership Cap” has the meaning set forth in the Stock Purchase
Agreement.
 
1.61           “Party” shall mean ANTHERA or ZENYAKU and “Parties” shall mean
both of them. ANTHERA and ZENYAKU, however, are sometimes also referred to as
“party” or the “parties.”
 
1.62           “Patents” shall mean patents and patent applications, including
provisional applications, continuations, continuations-in-part, continued
prosecution applications, divisionals, substitutions, reissues, additions,
renewals, reexaminations, extensions, term restorations, confirmations,
registrations, revalidations, revisions, priority rights, requests for continued
examination and supplementary protection certificates granted in relation
thereto, as well as utility models, innovation patents, petty patents, patents
of addition, inventor’s certificates, and equivalents in any country or
jurisdiction.
 
1.63           “Phase 3 Trial” shall mean a human clinical trial that would
satisfy the requirements for a Phase 3 study as defined in either 21 C.F.R. §
312.21(c) (or its successor regulation) or in the ICH E8 Guideline (or its
successor regulation); accordingly, a Phase 3 Trial may refer to a clinical
trial in any country that meets the foregoing standards.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
6.

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1.64           “Product” shall mean any pharmaceutical preparation for human use
containing the Compound as an active ingredient.
 
1.65           “Product Invention” means any Invention that constitutes or
relates in any way to the composition of matter, formulation, manufacture, or
use (including methods of administration) of a Compound or Product.
 
1.66           “Product Know-How” means any Information, processes, techniques,
Data, know-how, and trade secrets that constitute or relate in any way to a
Compound and/or the Product, including toxicological, pharmacological, clinical,
and chemical data, specifications, medical uses, adverse reactions, and
manufacture and quality control methods for a Compound or Product.
 
1.67           “Product Patent” shall mean any Patent that Covers a Compound or
Product.
 
1.68           “Product Supply Agreement” shall have the meaning provided in
Article 6.
 
1.69            “Regulatory Approval” shall mean any and all approvals
(including price and reimbursement approvals, if required), licenses,
registrations, or authorizations of any Regulatory Authority in any country or
other jurisdiction that are necessary to initiate or continue clinical
development and to market and sell Product in the Field in such country or
jurisdiction.
 
1.70           “Regulatory Authority” shall mean any country, federal,
supranational, state or local regulatory agency, department, bureau or other
governmental or regulatory authority having the administrative authority to
regulate the development or marketing of pharmaceutical products in any country
or other jurisdiction.
 
1.71           “Shared Cost Budget” shall mean a budget, mutually agreed to by
the parties, for the ANTHERA activities related to the [***] under the Joint
Development Plan.  The Shared Cost Budget is and shall be included in the Joint
Development Plan, listed in the Exhibit C.
 
1.72            “Shared Costs” shall mean any and all clinical development
expenses (including FTE and out-of-pocket expenses) for the Product for [***]
incurred by or on behalf of a party in accordance with the then-current Shared
Cost Budget.
 
1.73           “Shares” has the meaning set forth in the Stock Purchase
Agreement.
 
1.74           “SLE” shall mean Systemic Lupus Erythematosus.
 
1.75           “SLE Costs” shall mean any and all clinical development expenses
(including FTE and out-of-pocket expenses) for the Product [***].
 
1.76           “SLE Cost Budget” shall mean the budget in the Joint Development
Plan for the costs of the [***].
 
1.77           “Stock Purchase Agreement” means that certain stock purchase
agreement entered into by the parties, attached hereto as Exhibit E.
 
1.78           “Sublicensee” shall mean any Third Party to whom ZENYAKU or its
Affiliate has directly or indirectly granted a sublicense under all or any
portion of the License.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
7.

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1.79           “Term” shall have the meaning set forth in Article 13.
 
1.80           “Third Party” shall mean any entity other than ANTHERA or ZENYAKU
or an Affiliate of ANTHERA or ZENYAKU.
 
1.81            “Third Party Payments” shall have the meaning set forth in
Section 1.29.
 
1.82           “U.S.” or “U.S.A.” shall mean the United States of America.
 
1.83           “Valid Claim” shall mean a claim contained in an issued and
unexpired Patent, which claim has not been held unenforceable, unpatentable or
invalid by a decision of a court or other governmental agency of competent
jurisdiction, unappealable or unappealed within the time allowed for appeal, and
has not been admitted to be invalid or unenforceable through abandonment,
reissue, disclaimer or otherwise.
 
1.84            “ZENYAKU Development Plan” shall mean ZENYAKU’s written plan for
development of the Product in the ZENYAKU Territory. References to the ZENYAKU
Development Plan refer to the then-current version.
 
1.85            “ZENYAKU Invention” shall mean any Product Invention arising in
the course of activities conducted under this Agreement, that is made by one or
more employees or contractors (or personnel of contractors) of ZENYAKU or its
Affiliate and no employees or contractors (or personnel of contractors) of
ANTHERA or its Affiliate. ZENYAKU Inventions may be made together by one or more
employees or contractors (or personnel of contractors) of ZENYAKU or its
Affiliate, and any Third Party, including any Sublicensee, and in that case the
applicable ZENYAKU Invention is only to the extent of ZENYAKU’s or its
Affiliate’s ownership interest in the applicable Invention (recognizing that
ZENYAKU or its Affiliate may hold only an undivided interest in such Invention).
 
1.86           “ZENYAKU Know-How” shall mean all Product Know-How Controlled by
ZENYAKU or its Affiliates during the Term, including, without limitation, all
ZENYAKU Inventions.  For clarity, notwithstanding the foregoing, ZENYAKU
Know-How excludes general marketing, promotional, and distribution expertise of
ZENYAKU, whether or not used in the marketing, promotion, and/or distribution of
Compound and/or Product and excludes any rights under ZENYAKU Patents.
 
1.87           “ZENYAKU Option” shall have the meaning set forth in Section 2.2.
 
1.88           “ZENYAKU Patents” shall mean all Patents Controlled by ZENYAKU
during the Term that claim or first disclose any ZENYAKU Invention.  For
clarity, ZENYAKU Patents exclude Patents controlled by ZENYAKU during the term
independently of ZENYAKU’s activities under this Agreement that ZENYAKU does not
practice in its Compound and Product related activities.
 
1.89           “ZENYAKU Technology” shall mean the ZENYAKU Know-How and ZENYAKU
Patents and ZENYAKU’s interest in Joint Inventions and Joint Patents.
 
1.90           “ZENYAKU Territory” shall mean Japan or, if the ZENYAKU Option is
executed, Japan and all of the countries in the Option Territory.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
8.

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2.
License Grants

 
2.1           Exclusive License.  Subject to the terms and conditions of this
Agreement, ANTHERA hereby grants to ZENYAKU, during the Term, (a) an exclusive
(even as to ANTHERA, except as described below) license, with the right to grant
sublicenses through one or multiple tiers of sublicense (solely as permitted in
accordance with Section 2.3, and subject to Section 2.4), under the ANTHERA
Technology solely to develop, use, sell, have sold, offer for sale and import
Compounds and Products in the Field in the ZENYAKU Territory (the “License”),
(b) a co-exclusive (with ANTHERA, and except to the extent provided to be
exclusive even as to ANTHERA as set forth in  this Section 2.1) license, with
the right to grant sublicenses to Third Party contract manufacturers solely as
permitted in Section 4.9, under the ANTHERA Technology solely to make and have
made Compounds and Products in the Field anywhere in the world for purposes of
developing Compounds and Products for and offering for sale and selling
Compounds and Products in the ZENYAKU Territory (the “Manufacturing License”),
such Manufacturing License shall only be practiced as expressly permitted by
this Agreement pursuant to Sections 6.2, 7.1, 13.3 and/or the terms of the
Product Supply Agreement; and (c) a non-exclusive right, with the right to
sublicense to contractors as permitted in Section 2.3, under the ANTHERA
Technology (and all counterparts to the ANTHERA Technology within the ANTHERA
Territory) solely to perform or have performed assays in the ANTHERA Territory,
solely in support of ZENYAKU’s Compound and Product development activities for
Compounds and Products in the Field in the ZENYAKU Territory; provided that
ZENYAKU shall provide ANTHERA with prior written notice of any assay work to be
performed in the ANTHERA Territory.  Unless the parties otherwise mutually agree
in writing, the License shall not include the right for ZENYAKU, its Affiliates
or sublicensees to conduct clinical trials of Compound or Product in the ANTHERA
Territory (regardless of whether such clinical trials are in generation of data
to support Regulatory Approvals of Compounds or Products in the ZENYAKU
Territory).  For clarity, the License and Manufacturing License includes a
sublicense under the rights granted to ANTHERA by Amgen under the Amgen Patents,
including all rights of ANTHERA under the Amgen Agreement and Amgen Patents for
Compounds and Products in the Field in the ZENYAKU Territory.  The Manufacturing
License, at such times as ZENYAKU is entitled to practice the Manufacturing
License in accordance with this Agreement or the Product Supply Agreement, shall
be exclusive even as to ANTHERA, except to the extent that ZENYAKU elects to
continue to obtain supply from ANTHERA at such time in accordance with this
Agreement.  The Manufacturing License, to be clear, is not to the exclusion of
ANTHERA’s or an Other Licensee’s rights to manufacture or have manufactured
Compounds and Products for purposes of supplying the ANTHERA Territory.
 
2.2           Option for Option Territory.  At any time prior to , ZENAYAKU
shall have the right to expand the ZENYAKU Territory to include the countries of
the Option Territory (the “ZENYAKU Option”) by providing ANTHERA with a notice
(the “Option Notice”), and subject to the Ownership Cap and the other terms and
conditions set forth in the Stock Purchase Agreement, ZENYAKU shall purchase
from ANTHERA and ANTHERA shall sell to ZENYAKU an aggregate of $4,000,000 of
Shares, at the price per Share set forth on Exhibit A of the Stock Purchase
Agreement, provided, however, that if the number of such Shares that ZENYAKU may
purchase is limited by the Ownership Cap, ZENYAKU shall have no further
obligation to purchase any Shares pursuant to this Section 2.2 and the ZENYAKU
Territory shall still be expanded to include the Option Territory in that case.
The closing for such purchase of Shares shall take place remotely via the
exchange of documents and signatures at 4:00 p.m. (Pacific Time) on the date
stated in the Option Notice, which date shall be no less than 5 days nor more
than 30 days following the date that the Option Notice is delivered to ANTHERA
or such later time as ANTHERA and ZENYAKU may mutually agree.  Upon closing of
such purchase of Shares in accordance with the Stock Purchase Agreement, the
ZENYAKU Territory shall be deemed to include the Option Territory.  If ZENYAKU
fails to provide Option Notice to exercise such option by May 31, 2016 pursuant
to the Stock Purchase Agreement, its rights under this Section 2.2 shall lapse
and the Option Territory shall remain as part of ANTHERA’s Territory.  If
ZENYAKU fails to complete such purchase of Shares pursuant to the Stock Purchase
Agreement, then its rights under this Section 2.2 shall lapse and the Option
Territory shall remain as part of ANTHERA’s Territory.  Notwithstanding the
foregoing, this Section 2.2 shall lapse and have no effect in the event that (a)
this Agreement is assigned to a Third Party in connection with the transfer or
sale of all or substantially all of the business of ANTHERA, whether by merger,
sale of stock, sale of assets or otherwise, in a bona fides transaction in which
there is a change “control” of ANTHERA (as “control” is described in the
definition of “Affiliate”) and, to avoid doubt, no class nor combination of
classes of shareholders of ANTHERA from prior to the transaction has “control”
of the surviving entity (this is defined as an “Industry Transaction” of
ANTHERA; an “Industry Transaction” of ZENYAKU shall have a correlative meaning);
and (b) ZENYAKU received no less than 30 days prior written notice of the
Industry Transaction or such period of time as otherwise agreed by the Parties.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
9.

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2.3           Sublicenses.
 
(a)                   Any and all sublicenses granted under the License shall be
in writing and shall be subject to, and consistent with, the terms and
conditions of this Agreement.  ZENYAKU shall be fully responsible for the
compliance of its Affiliates and Sublicensees with the terms and conditions of
this Agreement.  Within 30 days prior to execution, ZENYAKU shall provide
ANTHERA with a draft copy of each sublicense agreement (provided that ZENYAKU
may redact any sensitive or confidential information contained therein that is
not necessary to ascertain compliance with this Agreement) and ZENYAKU shall
consider in good faith any comment provided by ANTHERA with respect to such
sublicense, although the final terms and wording of the sublicense, and the
decision whether or not to enter into the sublicense, shall be in ZENYAKU’s
discretion (provided that all terms and wording of each sublicense shall be
consistent with the terms and conditions of this Agreement).  Promptly following
execution of such sublicense agreement, ZENYAKU shall provide ANTHERA with a
full and complete copy of such sublicense agreement (provided that ZENYAKU may
redact any sensitive or confidential information contained therein that is not
necessary to ascertain compliance with this Agreement).  ZENYAKU shall not be
required to share with ANTHERA a copy of any agreement providing a Manufacturing
License sublicense to a contract manufacturer.
 
(b)                   In the event that ZENYAKU or its Affiliate grants a
sublicense to Sublicensee of any rights granted by ANTHERA under Section 2.1,
ZENYAKU hereby agrees that it shall use Commercially Reasonable Efforts to
obtain from such Sublicensee for no additional consideration a grant-back to
ZENYAKU for the ANTHERA Territory of any Sublicensee Inventions (defined below
in this Section 2.3(b)) (and all Patents covering such inventions) that is
substantially similar to (and in any event at least as broad as) the license
granted by ANTHERA to ZENYAKU in Section 2.1 (but with respect to the ANTHERA
Territory) (replacing all references to the “ZENYAKU Territory” under Section
2.1 with “ANTHERA Territory”) (the “Sublicensee Grant-Back License”).  The
applicable Sublicensee’s Sublicensee Inventions will be deemed ZENYAKU
Technology hereunder and included within the license granted to ANTHERA under
Section 2.7(a).  Each Sublicensee Grant-Back License shall include the right to
sublicense to ANTHERA all of the foregoing within the full scope of the license
granted under Section 2.7(a) for no additional consideration, for ANTHERA to
further sublicense through one (1) or more tiers of sublicensees without the
need to obtain consent, and upon ANTHERA’s election, for such Sublicensee
Grant-Back License to survive any termination of this Agreement.  For this
purpose “Sublicensee Inventions” means Product Inventions, Product Know-How and
Product Patents that (i) are invented by such Sublicensee (and/or its Affiliate
or contractor) in the course of activities for the development, manufacture or
commercialization of the Compounds or Products or otherwise in the exercise of
the sublicensed rights, in each case, during the term of the applicable
Sublicensee and (ii) would otherwise meet the definition of ZENYAKU Technology
if made by ZENYAKU under this Agreement.  Notwithstanding anything express or
implied in this Agreement, ZENYAKU (X) shall not sublicense ANTHERA Technology,
to the extent of any Other Licensee Inventions therein, to any Sublicensee who
does not provide the Sublicensee Grant-Back License (including such right to
sublicense to ANTHERA through multiple tiers), and (Y) shall not sublicense nor
subcontract its Initial Indication and/or SLE development activities to any
Sublicensee who does not provide the Sublicensee Grant-Back License (including
such right to sublicense to ANTHERA through multiple tiers).
 
2.4           ANTHERA Reserved Rights.  Notwithstanding the exclusive licenses
granted to ZENYAKU pursuant to Section 2.1, and without limiting the generality
of Section 2.10, ANTHERA hereby expressly reserves the right to practice, and to
grant licenses (through multiple tiers) under, the ANTHERA Technology to (a)
perform (or have performed by permitted subcontractors hereunder) its activities
under, and exercise of its rights under, this Agreement, in each case in
furtherance of the development activities under the Joint Development Plan to be
conducted by ANTHERA and its Affiliates under this Agreement and/or in support
of the ANTHERA Territory, (b) the right to manufacture and have manufactured
Compounds and Products anywhere in the world for the purpose of (i) supplying
ZENYAKU Compound and Product pursuant to the Product Supply Agreement and (ii)
the use, sale, offer for sale and import of such Compounds and Products in the
ANTHERA Territory, and (c) the right to conduct or have conducted clinical
trials and other studies of Compounds and Products anywhere in the world
(including the ZENYAKU Territory upon prior written consent of ZENYAKU). Without
limiting the generality of the foregoing, ANTHERA shall at all times have the
exclusive right to develop, manufacture and commercialize, and to grant licenses
to Affiliates and Third Parties to develop, manufacture and commercialize,
Compound and Product in the ANTHERA Territory (but not to the exclusion of
ZENYAKU’s non-exclusive assay right in accordance with Section 2.1, and not to
the exclusion of the Manufacturing License, which is worldwide).
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
10.

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2.5           ANTHERA Right of First Negotiation.  In the event ZENYAKU
anticipates entering into a co-development, co-promotion, or co-marketing
agreement with a Third Party with respect to the Product in one or more
countries in the ZENYAKU Territory, and A[***]. ANTHERA shall have [***] to give
written notice to ZENYAKU that it desires to enter into such negotiations, and
if it does provide such notice of the same, then ZENYAKU shall negotiate
diligently and in good faith with ANTHERA [***]. If ANTHERA does not give timely
notice of its desire to enter into negotiations, or if ANTHERA does give timely
notice but no agreement is entered into between the parties within [***] then
ZENYAKU shall be [***].  If ZENYAKU has not entered into a co-development,
co-promotion, or co-marketing agreement with a Third Party within [***] after
the latest of (a) [***] from its original notification to ANTHERA in the event
that no response was provided by ANTHERA or the date of ANTHERA’s response if
ANTHERA responded that it did not wish to negotiate, or (b) expiration of the
[***] negotiation period with ANTHERA (or such earlier time as ANTHERA provided
written notice that it no longer elected to negotiate), then ANTHERA’s right of
first negotiation pursuant to this Section 2.5 shall again be in effect at the
end of such [***] period.
 
2.6           Negative Covenants.  During the Term, ZENYAKU hereby covenants not
to practice, and not to permit or cause any Affiliate, Sublicensee, or Third
Party to practice, any ANTHERA Technology for any purpose other than as
expressly authorized in this Agreement. Without limiting the generality of the
foregoing, ZENYAKU hereby covenants: (a) not to develop, use, sell, have sold or
offer for sale Compound or Product outside the ZENYAKU Territory or outside of
the Field; (b) except as expressly permitted under the Product Supply Agreement
or this Agreement, not to make or have made Compound or Product; and (c) not to
grant, or purport to grant, any Affiliate of ZENYAKU or any Third Party any
license or other right to do any of the foregoing.  For clarity, nothing in this
Section 2.6 shall limit ZENYAKU’s license under Section 2.1(c) to perform or
have performed assay work in the ANTHERA Territory for the purpose of supporting
development and commercialization of Compound and Products in the Field in the
ZENYAKU Territory.
 
2.7           License Grant-Back to ANTHERA.
 
(a)                   ZENYAKU hereby grants to ANTHERA an exclusive (even as to
ZENYAKU, except as expressly set forth below), license, with the right to
sublicense through multiple tiers of sublicense, under the ZENYAKU Technology
and ZENYAKU’s interest in the Joint Patents solely: (a) to develop, make, have
made, use, sell, have sold, offer for sale and import Compound and Product in
the ANTHERA Territory; and (b) to make and have made Compound and Product in the
ZENYAKU Territory for the sole purpose of use, sale, offer for sale and import
of such Compound and Product in the ANTHERA Territory and to supply such
Compound and Product to ZENYAKU pursuant to the Product Supply Agreement
(collectively, the “Grant-Back License”); provided, however, that the
exclusivity of the Grant-Back License will be subject to ZENYAKU’s reserved
right to make and have made Compound and Product in the ANTHERA Territory for
the sole purpose of develop, use, sale, offer for sale and import of such
Compound and Product in the ZENYAKU Territory and to conduct the activities in
the ANTHERA Territory set forth in Section 2.1(c).
 
(b)                   In the event that ANTHERA or its Affiliate enters into an
Other License, ANTHERA hereby agrees that it shall use Commercially Reasonable
Efforts to obtain from the Other Licensee for no additional consideration a
grant-back to ANTHERA for the ZENYAKU Territory of any Other Licensee Inventions
(and all Patents covering such inventions) that is substantially similar to (and
in any event at least as broad as) the license granted by ZENYAKU to ANTHERA in
Section 2.7(a) (but with respect to the ZENYAKU Territory) (replacing all
references to the “ANTHERA Territory” under Section 2.7(a) with “ZENYAKU
Territory) (the “Other Licensee Grant-Back License”).  The applicable Other
Licensee’s Other Licensee Inventions (defined below) will be deemed ANTHERA
Technology hereunder and included within the license granted to ZENYAKU under
Section 2.1.  Each Other Licensee Grant-Back License shall include the right to
sublicense to ZENYAKU all of the foregoing within the full scope of the license
granted to ZENYAKU under Section 2.1, for no additional consideration, for
ZENYAKU to further sublicense through one (1) or more tiers of sublicensees
without the need to obtain consent, and upon ZENYAKU’s election, for such Other
Licensee Grant-Back License to survive any termination of this Agreement. For
this purpose “Other Licensee Inventions” means Product Inventions, Product
Know-How and Product Patents that (i) are invented by such Other Licensee
(and/or its Affiliate or contractor) in the course of activities for the
development, manufacture or commercialization of the Compounds or Products or
otherwise in the exercise of the sublicensed rights, in each case, during the
term of the applicable Other License and (ii) would otherwise meet the
definition of ZENYAKU Technology if made by ZENYAKU under this Agreement.  Each
Other Licensee Grant-Back License shall also include the right for ZENYAKU to
make and have made Compound and Product anywhere in the world in support of
activities for the ZENYAKU Territory.  Notwithstanding anything express or
implied in this Agreement, ANTHERA (X) shall not sublicense ZENYAKU’s Grant-Back
License to any Other Licensee who does not provide the Other Licensee Grant-Back
License (including such right to sublicense to ZENYAKU through multiple tiers),
and (Y) shall not sublicense nor subcontract its Initial Indication and/or SLE
development activities to any Other Licensee who does not provide the Other
Licensee Grant-Back License (including such right to sublicense to ZENYAKU
through multiple tiers).
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
11.

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2.8           Combination Products.  The Products of this Agreement are defined
to include combinations of Compound with other active ingredient(s).  However,
if ANTHERA has Patents that Cover the other active ingredient(s) independently
of their combination with Compound, then those Patents are not licensed to
ZENYAKU under this Agreement, to the extent covering such other active
ingredients independently of their combination with Compound, unless and except
to the extent that ANTHERA proceeds to develop such combination
Product.  Similarly, if ZENYAKU has Patents that Cover the other active
ingredient(s) independently of their combination with Compound, then those
Patents are not licensed to ANTHERA under this Agreement, to the extent covering
such other active ingredients independently of their combination with Compound.
 
2.9           Competing Products.
 
(a)                   ANTHERA. During the Term and subject to the terms and
conditions of this Agreement, ANTHERA and its Affiliates shall not, directly or
indirectly, by itself (or themselves) or through collaborating with or granting
rights to a Third Party, clinically develop or commercialize any Competing
Product anywhere in the world.  To avoid doubt, this Section 2.9(a) shall not
prohibit ANTHERA, its Affiliates and their sublicenses (through multiple tiers)
from (i) exercising the rights retained by them pursuant to Section 2.4, and
(ii) researching, developing or commercializing any Compound or Products in the
ANTHERA Territory.
 
(b)                   ZENYAKU.  During the Term and subject to the terms and
conditions of this Agreement, ZENYAKU and its Affiliates shall not, directly or
indirectly, by itself (or themselves) or through collaborating with or granting
rights to a Third Party, clinically develop or commercialize any Competing
Product anywhere in the world.
 
2.10           No Implied Licenses.  No right or license under any Patents or
Information of either party is granted or shall be granted by implication.  All
such rights or licenses are or shall be granted only as expressly provided in
this Agreement.
 
3.
Governance

 
3.1           Joint Development Committee.  Promptly after the Effective Date,
the Parties shall establish a joint development committee (the “Joint
Development Committee” or “JDC”) that will oversee ZENYAKU’s and ANTHERA’s
development activities under this Agreement and facilitate communications
between the Parties with respect to the development of the Product.
 
(a)                   Composition.  The JDC shall be composed of two (2)
representatives for each of ANTHERA and ZENYAKU for a total of four (4), each of
whom shall have appropriate experience, knowledge and authority within such
party’s organization to carry out the duties and obligations of the JDC. Each
party shall designate one of its representatives as the primary contact for that
party with respect to JDC-related matters. Each party may change its
representatives to the JDC or its primary contact from time to time in its sole
discretion, effective upon notice to the other party of such change. These
representatives shall have appropriate experience and knowledge. A reasonable
number of additional representatives of a party may attend meetings of the JDC
in a non-voting capacity.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
12.

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(b)                   Responsibilities.  The JDC’s overall responsibility shall
be to facilitate information sharing and coordination between the parties in the
development, registration and commercialization of Product in the Field in each
the ANTHERA Territory and the ZENYAKU Territory.  The specific responsibilities
of the JDC shall be:
 
(i)         to serve as the primary means by which: (1) the parties review and
discuss the Joint Development Plan (including the Shared Cost Budget and SLE
Cost Budget), as amended from time to time in accordance with Article 4;
(2) ZENYAKU consults with ANTHERA and considers in good faith ANTHERA’s comments
and suggestions regarding Product development activities to be conducted in the
ZENYAKU Territory; and (3) ANTHERA provides ZENYAKU with updates regarding
Product development activities to be conducted in the ANTHERA Territory outside
the Joint Development Plan as well as any planned Compound or Product
development in the ZENYAKU Territory, and ANTHERA consults with ZENYAKU and
considers in good faith any concerns relating to any of the foregoing that
ZENYAKU may have;
 
(ii)         to serve as the primary means by which: (1) the parties review and
discuss the ZENYAKU Development Plan, as amended by ZENYAKU from time to time in
accordance with Article 4; and (2) ZENYAKU consults with ANTHERA and considers
in good faith ANTHERA’s comments and suggestions regarding ZENYAKU Development
Plan activities;
 
(iii)         to facilitate the exchange of ANTHERA Know-How (excluding
manufacturing Know-How, the disclosure of which shall be governed by the Product
Supply Agreement, except as provided for in this Agreement, including in
Articles 4 and 6) and ZENYAKU Know-How;
 
(iv)         to serve as the principal means by which ANTHERA keeps ZENYAKU
informed regarding ANTHERA’s development, registration and commercialization
plans, efforts and results with respect to Compound and Product in the Field in
the ANTHERA Territory, and by which ZENYAKU keeps ANTHERA informed regarding
ZENYAKU’s development, registration and commercialization plans, efforts and
results with respect to Compound and Product in the Field in the ZENYAKU
Territory;
 
(v)         to seek harmonization in global development, regulatory approval,
marketing, promotion and commercialization efforts with respect to Compound and
Product in the Field;
 
(vi)         to informally resolve disputes where possible to resolve by
consensus; and
 
(vii)         to carry out such other obligations as are expressly delegated to
it under this Agreement. The JDC’s responsibilities and authority shall be
limited to those matters expressly delegated to it in this Agreement.
 
(c)                   Meetings.
 
(i)         The JDC shall meet as deemed necessary by the JDC members, but at
least quarterly, with the location for such meetings alternating between ANTHERA
and ZENYAKU facilities (or such other location as is mutually agreed by the
parties).  Alternatively, the JDC may meet by means of teleconference,
videoconference or other similar communications equipment.  At least one meeting
per year will be in person.  Each party shall be responsible for all of its own
expenses of participating in JDC meetings.
 
(ii)         If ANTHERA grants rights to an Other Licensee, then to the extent
such Other Licensee agrees, the JDC of this Agreement will in general meet
jointly with a joint development committee or steering committee formed under
the Other License, to ensure the best collaboration and coordination in the
global development process, across all relevant companies.  For clarity, it is
understood that the JDC of this Agreement if desired by either party to this
Agreement would meet without the Other Licensee’s representatives present (and
that the committee of the other agreement might do the same).  It is also
understood that the joint meetings with the joint committees of Other Licenses
could be by teleconference, videoconference, or other similar communications
equipment.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
13.

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(d)                   Minutes.  Responsibility for preparing definitive minutes
of each JDC meeting shall alternate between the parties, with ANTHERA having
responsibility for preparing minutes of the first JDC meeting.  The responsible
party shall circulate a draft of the minutes of each meeting to all members of
the JDC for comments within 10 business days (i.e. that is days that are not
national holidays in the home country of the party responsible to prepare the
minutes) after such meeting. Such minutes shall provide a description, in
reasonable detail, of the discussions at the meeting and shall document all
actions and determinations approved by the JDC at such meeting.  The parties
shall promptly discuss any comments on such minutes and finalize the minutes no
later than the date of the next JDC meeting.  The JDC’s meeting minutes,
regardless of whether signed by the JDC members, shall not be deemed to amend,
modify or waive compliance with this Agreement.
 
(e)                   Decision-Making.  Decisions of the JDC shall be made by
consensus (or unanimous vote), with each party’s representatives on the JDC
having together one collective vote on behalf of that party.
 
(f)                   Dispute Resolution. If the JDC is unable to decide or
resolve unanimously any matter properly presented to it for action, at the
written request of either party, the issue shall be referred to the Chief
Executive Officer of ANTHERA and the Chief Executive Officer of ZENYAKU (or his
or her designee) who shall promptly meet and attempt in good faith to resolve
such issue within 30 days.  Notwithstanding the foregoing, if such Chief
Executive Officers (for ZENYAKU, such Chief Executive Officer or his or her
designee) cannot resolve such matter within 30 days of the date such matter is
first referred to them, then:
 
(i)         If the matter is with respect to any change to the Joint Development
Plan that:
 
(1)           [***]
 
(2)           [***]
 
(3)           [***]
 
(4)           [***]
 
 
 
 
(ii)         ANTHERA’s Chief Executive Officer shall have the final
decision-making authority with respect to (1) ANTHERA Development Plan,
including any changes and implementation of such ANTHERA Development Plan; (2)
the conduct of the CHABLIS-SC1 Study; (3) changes to and implementation of the
Joint Development Plan (and the activities therein), subject to Section
3.1(f)(i); or (4) relating to the research, development, manufacture, marketing,
promotion and commercialization of Compounds and Products in the Field within
the ANTHERA Territory; and
 
(iii)         ZENYAKU’s CEO (or his or her designee) shall have the final
decision-making authority with respect to (1) the ZENYAKU Development Plan,
including any changes and implementation of the ZENYAKU Development Plan; or (2)
relating to the marketing, promotion and commercialization strategy with respect
to Product in the Field within the ZENYAKU Territory.
 
However, in the event of a fundamental difference of opinion between the parties
regarding any of the matters described in Sections 3.1(f)(ii) and 3.1(f)(iii),
the applicable officer (or his or her designee) of the party having final
decision-making authority shall give good faith consideration to the other
party’s position and make reasonable efforts to take the other party’s position
into account in making his or her decision; moreover, and notwithstanding the
foregoing or any other provision of this Agreement to the contrary, neither the
JDC nor any individual with dispute-resolution authority under this
Section 3.1(f) shall have any power to: (A) determine any issue in a manner that
would conflict with the express terms and conditions of this Agreement or
(B) modify or amend the terms and conditions of this Agreement.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
14.

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(g)                   Existence.  After its establishment, the JDC shall remain
in place during the Term for so long as either party is conducting any
development or commercialization activities.  Following first commercial sale of
a Product, the parties will discuss and agree whether the JDC should continue to
meet at the same frequency as provided herein.
 
(h)                   Limited Powers.  The JDC shall have only those powers
explicitly provided for it above, or as expressly provided elsewhere in this
Agreement for the JDC to perform.  The JDC shall have no power to amend, modify
or waive compliance with this Agreement.
 
4.
Development

 
4.1           Development Plans.
 
(a)                   Joint Development Plan.
 
(i)         Definition and Background.  The parties have agreed and attached to
this Agreement as Exhibit C an initial development plan for certain development
of Compound and Product by ANTHERA for the Initial Indication and SLE (the
“Joint Development Plan”), which activities are intended to support the global
development of Compound and Product for these Indications (i.e., they generate
data that is expected to be useful in both the ANTHERA Territory and the ZENYAKU
Territory).  Within ninety (90) days of the Effective Date, ANTHERA shall update
the initial Joint Development Plan.  Such update shall be subject to the
limitations provided in Article 3, including Section 3.1(f), and shall be
subject to ratification (or modification followed by ratification) of the
JDC.  Such update shall not modify either the Shared Cost Budget or the SLE Cost
Budget, subject to Section 3.1(f).  For those Joint Development Plan activities
for the Initial Indication, the Shared Cost Budget has been included in the
Joint Development Plan, and the parties are sharing the costs incurred under and
in accordance with the Shared Cost Budget as provided for in Section 7.4.  For
those Joint Development Plan activities for SLE, the SLE Cost Budget has been
included in the Joint Development Plan.  As between the parties, ANTHERA will
initially bear all of the Shared Cost, subject to partial reimbursement by
ZENYAKU in accordance with Section 7.4(a)(ii). As between the parties, ANTHERA
will initially bear all of the SLE Costs, subject to partial reimbursement by
ZENYAKU in accordance with Section 7.4(b)(i) in the circumstances described in
such Section.
 
(ii)         Process for Changes to Plan.
 
(1)           Changes with respect to the Initial Indication.  Either party may
propose changes with respect to the Initial Indication to the Joint Development
Plan (which may include changes to the Shared Cost Budget) from time to time,
via the JDC.  The JDC shall discuss such changes to the Joint Development Plan
(which may include changes to the Shared Cost Budget requested by either
party).  The JDC shall also review the Joint Development Plan (including such
budgets) annually.  Any changes to the Joint Development Plan with respect to
the clinical protocol or territorial distribution of subjects for any clinical
trial for the Initial Indication shall be made only by the mutual written
approval of the parties.  Any changes to the to the Shared Cost Budget, which
increase such budget by [***], individually or aggregated together with other
Shared Cost Budget changes that were not made by consensus, shall be made only
by the mutual written approval of the parties.  Any such mutual written approval
may be either in the form of a JDC action unanimously approved by the parties,
or in the form of a written amendment signed by authorized officers of both
parties.  If one party wishes to make a change to any element of the Joint
Development Plan with respect to the Initial Indication, that is described above
to require consensus between the parties, then the change shall not be made and
the matter shall not be referred to arbitration in accordance with Article 15
nor shall it be justiciable.  If one party wishes to make a change to any
element of the Joint Development Plan for the Initial Indication other than in a
way that require consensus between the parties as described above in this
Section, the matter shall be resolved in accordance with Section 3.1(f).  Each
Party hereby acknowledges that amendments to clinical protocols that require
submission to a Regulatory Authority or material changes in the territorial
distribution of patients, even when not having a budgetary impact, can have a
material impact on the utility of the resulting data to each Party in its
respective territory, and therefore such changes in clinical protocols and
territorial distributions in trials for the Initial Indication shall be made
only by consensus.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
15.

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(2)           [***] .
 
(iii)         Overall Scope.  The parties intend that the Joint Development Plan
activities shall include all activities that, if the trials described there are
favorable, are required to obtain B.L.A. approval in the U.S. for the Initial
Indication (it being understood that the parties anticipate
ZENYAKU-Territory-specific trials will additionally be required to obtain B.L.A.
approval in Japan for this indication; and that these ZENYAKU Territory-specific
clinical trials for the Initial Indication would be conducted by ZENYAKU under
the ZENYAKU Development Plan), and all trials that (if favorable) would be
required in order to obtain B.L.A. approval in the U.S. and in Japan for SLE
(such that no additional Japan-specific trials are anticipated by the parties to
be required to support Japanese Regulatory Approval of Product to treat SLE if
sufficiently favorable results are generated in the Joint Development Plan
trials).  The parties may, but are not required to, mutually agree to include
other shared development for other indications in the Shared Cost Budget within
the Joint Development Plan in the future, but neither party shall be required to
agree to such an expansion (nor to any other change to the Shared Cost Budget in
the absence of written consensus between the parties).  If the parties agree to
include other indications within the Shared Cost Budget and the Joint
Development Plan in the future, then they shall discuss and agree at the time on
any corresponding amendments to the process for changing the such budget and
plan with respect to the added indications, including limitations on unilateral
changes to such budget and plan with respect to the added indications.
 
(b)                   ANTHERA Development Plan.  Within [***]  days of the
Effective Date, ANTHERA shall provide ZENYAKU with an ANTHERA Development Plan,
which shall describe any activities that ANTHERA plans to conduct for the
Product (including the CHABLIS-SC1 Study), other than those set forth in the
Joint Development Plan.  Such ANTHERA Development Plan shall include all planned
development activities of ANTHERA and its Affiliates.  ANTHERA shall provide an
updated version of the ANTHERA Development Plan to ZENYAKU annually, no later
than [***] days prior to the last JDC meeting that will occur that year.  To the
extent any Other Licensee agrees, ANTHERA shall also include in the ANTHERA
Development Plan all planned Other Licensee Compound and Product activities
known to ANTHERA subject to ANTHERA’s right to disclose to ZENYAKU such
activities, and ANTHERA shall use Commercially Reasonable Efforts to obtain such
right to disclose to ZENYAKU.  ANTHERA shall not share ZENYAKU Development Plan
information with any Other Licensee who does not provide a commensurate amount
of information about its own plans to ANTHERA with the right to disclose to
ZENYAKU.
 
(c)                   ZENYAKU Development Plan.  In the event that ZENYAKU plans
to conduct any development activities for Products that are not included in the
Joint Development Plan, ZENYAKU shall provide ANTHERA with a ZENYAKU Development
Plan setting forth such activities.  The ZENYAKU Development Plan shall include
all planned development activities of ZENYAKU, its Affiliates, and
Sublicensees.  ZENYAKU shall provide an updated version of the ZENYAKU
Development Plan to ANTHERA annually, no later than 30 days prior to the last
JDC meeting that will occur that year. ZENYAKU shall discuss any updates with
ANTHERA through the JDC, in order to allow for coordination between the parties
on future plans, and in order to have the opportunity for ANTHERA to express any
concerns and for ZENYAKU to reasonably consider such concerns.  ZENYAKU shall
only modify the ZENYAKU Development Plan in accordance with this Agreement.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
16.

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4.2            ANTHERA Development.
 
(a)                   General.  All Compound and Product development by ANTHERA
and its Affiliates (and each Other Licensee, to the extent that any activity
under the Joint Development Plan is conducted by such Other Licensee) under this
Agreement shall be in accordance with the Joint Development Plan. ANTHERA shall
use Commercially Reasonable Efforts to initiate, conduct, or have conducted,
those development and registration activities with respect to Product as are
necessary to complete and submit to a Regulatory Authority a B.L.A. for Product
to treat the Initial Indication and SLE (and other Follow-On Indication, if that
is included in the Joint Development Plan) as set forth in the Joint Development
Plan and the Shared Cost Budget, SLE Cost Budget (and budget for other Follow-On
Indication, if that is included in the Joint Development Plan) and in accordance
with any applicable timelines set forth therein.  ANTHERA shall keep the JDC
regularly informed of the status, progress and results of all Joint Development
Plan activities (including the activities of ANTHERA and its
Affiliates).  [***].
 
(b)                   ZENYAKU Territory.  ZENYAKU recognizes that ANTHERA may
from time to time need to conduct or otherwise benefit from conducting
activities in the ZENYAKU Territory to facilitate Product development in the
ANTHERA Territory.  Certain such activities, including certain specified
clinical trials within the ZENYAKU Territory for SLE, have been approved by
ZENYAKU and included in the Joint Development Plan.  If ANTHERA wishes to
conduct any other clinical trial of Compound or Product in the ZENYAKU Territory
(i.e. other than those outlined in the Joint Development Plan), ANTHERA shall
discuss the matter with ZENYAKU via the JDC, and provide ZENYAKU with advance
written notice prior to taking any action to initiate such a trial in the
ZENYAKU Territory.  No such clinical trial in the ZENYAKU Territory shall be
included in the ANTHERA Development Plan without ZENYAKU’s advance written
notice at least [***] days prior to initiation of any clinical trial in the
ZENYAKU Territory, and no such trial ANTHERA in the ZENYAKU Territory shall
interfere with ZENYAKU’s development in the ZENYAKU Territory.
 
4.3           ZENYAKU Development.  The ZENYAKU Development Plan will set forth
the Product development activities to be conducted by or on behalf of ZENYAKU
for the ZENYAKU Territory. With the exception of that portion of any Joint
Development Plan activity that supports Product development in the ZENYAKU
Territory (by way of background, as of signing, there are ZENYAKU
Territory-specific SLE clinical trials included in the Joint Development Plan,
which will be conducted by ANTHERA), ZENYAKU shall be solely responsible for
conducting, at ZENYAKU’s sole expense, such development and registration
activities as may be required by Regulatory Authorities in the ZENYAKU Territory
to support Regulatory Approval for Product in the ZENYAKU Territory, using the
efforts required under Section 4.5 (and no greater effort than required by such
Section 4.5 shall be deemed required by this Section 4.3).  ZENYAKU shall keep
the JDC regularly informed of the status, progress and results of all ZENYAKU
Product development activities.
 
4.4           Performance Standards.  In conducting any Product development
activity, each party shall: (i) comply with all applicable laws, rules and
regulations and international regulatory standards, including, as applicable,
cGLPs, cGMPs, and cGCPs; and (ii) prepare and maintain, or shall cause to be
prepared and maintained, complete and accurate written records, accounts, notes
and reports in good scientific manner and in sufficient detail for patent and
regulatory purposes, which shall fully and properly reflect all work done,
results achieved, Data generated, and Inventions made in whole or in part, by
such party.  Each party shall, upon the reasonable request of the other party,
make such records available to the other party for inspection or copying.
 
4.5           Diligence.
 
(a)                   ZENYAKU shall use Commercially Reasonable Efforts to
develop, seek Regulatory Approval for and commercialize the Product for the
Initial Indication and for SLE in the ZENYAKU Territory; provided that ANTHERA
shall be responsible for activities within the Joint Development Plan with
respect to clinical trials for the Initial Indication and CHABLIS-SC2 Study
contained therein, as well as to conduct the CHABLIS-SC1 Study.  It is
understood and agreed that ZENYAKU’s regulatory package to seek approval for the
Initial Indication and SLE will include, and approval in the ZENYAKU Territory
for the Initial Indication and SLE will depend upon, respectively (x) the data
for the Initial Indication that will be generated by ANTHERA for this indication
under the Joint Development Plan, and (y) the data for SLE that will be
generated by ANTHERA in conducting the CHABLIS-SC1 Study and the CHABLIS-SC2
Study in the Joint Development Plan.  Accordingly, if ANTHERA fails to conduct
the activities within the Joint Development Plan necessary to generate the data
for the Initial Indication, or fails to conduct the CHABLIS-SC1 Study or the
activities within the Joint Development Plan necessary to generate the data for
SLE, then ZENYAKU’s ability to develop and seek Regulatory Approval in the
ZENYAKU Territory may be harmed and ZENYAKU shall not to be deemed in breach of
its diligence obligation set forth in the first sentence of this Section.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
17.

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(b)                   Should ZENYAKU choose to develop the Product for any other
Indication, it must so notify ANTHERA in writing (e.g., through the process
described above for updating the ZENYAKU Development Plan).  If ANTHERA has any
concerns, the parties shall convene a meeting of the JDC to discuss the matter,
and ZENYAKU shall reasonably consider ANTHERA’s concerns.  ZENYAKU shall not
have any obligation to devote Commercially Reasonable Efforts for any Indication
other than the Initial Indication (express or implied, at law or in equity), and
its Commercially Reasonable Efforts obligations for the Initial Indication are
subject to the limitations and conditions above in Section 4.5(a).
 
4.6           Technology Transfer - Assistance by ANTHERA.
 
(a)                   Commencing [***] the Effective Date, ANTHERA shall
disclose to ZENYAKU protocols and draft and final reports of any and all
preclinical study and any human clinical trial relating to pharmacology,
toxicology, or pharmacokinetic Data with respect to Compound or Product in the
Field.  ANTHERA shall also disclose and provide technology transfer to ZENYAKU
of all other ANTHERA Know-How used or needed for the further clinical
development of Compound and Product in the Field in the ZENYAKU Territory,
including any and all quality control assays and other assays or laboratory
tests relevant for clinical trials of Compound and Product.  ANTHERA shall use
Commercially Reasonable Efforts to complete the initial technology transfer
under this Section within [***] after the Effective Date unless the parties
working together mutually consent in writing to a longer time period.  ZENYAKU
shall not be charged for this initial technology transfer.
 
(b)                   ANTHERA acknowledges that ANTHERA is obligated to disclose
to ZENYAKU information relating to the manufacture of the Compound and Product
as necessary for the submission of regulatory filings for Regulatory Approval in
the ZENYAKU Territory.  Accordingly, ANTHERA shall disclose, and cause its
contractors involved in Compound and Product manufacturing to disclose, to
ZENYAKU any manufacturing and CMC-related Information necessary for such
regulatory filings submitted for Regulatory Approval in the ZENYAKU
Territory.  ZENYAKU may request such disclosure during the Term beginning six
(6) months prior to the estimated completion of the first Phase 3 Trial for a
Product in Japan and ANTHERA shall promptly comply with such request.  ZENYAKU
and ANTHERA shall work together jointly to identify and clearly specify what
information and documents must be supplied to allow for compliance with the
regulatory requirement, and ANTHERA shall promptly disclose such identified and
clearly specified information and documents.  The form of such disclosure shall
be electronic, if requested by ZENYAKU in writing.  ZENYAKU shall reimburse
ANTHERA for all FTE costs and out-of-pocket costs incurred by ANTHERA and its
Affiliates with respect to such technology transfer for information necessary or
required for any activities (including clinical trials) only in Japan.  If any
regulatory requirement requires ZENYAKU to submit CMC-related Information to the
ZENYAKU Territory regulator at an earlier stage than described in this Section
(for example, if required in connection with any IND in the ZENYAKU Territory,
nor or in the future), then the technology transfer of this Section shall occur
sufficiently in advance of such earlier stage to allow ZENYAKU to comply with
such regulatory requirement.
 
(c)                   During the Term, at ZENYAKU’s reasonable request, ANTHERA
will cooperate with ZENYAKU to provide such reasonable technical assistance as
may be necessary in connection with the development of the Product in the
ZENYAKU Territory as is consistent with the capacity and capabilities of
ANTHERA. As part of such assistance, ANTHERA will use reasonable efforts to
furnish a representative or representatives to attend drug regulatory meetings
regarding the Product and/or participate in activities related to such drug
regulatory meetings at ZENYAKU’s cost and expense. ANTHERA shall provide
reasonable technical assistance under this Section 4.6(c), and ZENYAKU will
reimburse ANTHERA at the ANTHERA FTE Rate plus any out-of-pocket expenses
incurred in connection with providing such assistance, in the case that ZENYAKU
requests this assistance.  There shall be no charge for the time of ANTHERA
personnel devoted to compliance with the regulatory reporting obligations stated
elsewhere in this Agreement, including in Section 4.8 or 4.12 below.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
18.

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4.7           Regulatory.
 
(a)                   Regulatory Responsibility in the ZENYAKU Territory.
 
(i)         General.  Following the Effective Date, ZENYAKU shall be solely
responsible for preparing, filing, obtaining and maintaining Regulatory
Approvals for Products in the Field in the ZENYAKU Territory.  As between the
parties, ZENYAKU shall be the holder of all Regulatory Approvals for Products in
the Field in the ZENYAKU Territory and shall have responsibility for all
interactions with Regulatory Authorities with respect to Products in the Field
in the ZENYAKU Territory.  ZENYAKU shall promptly provide ANTHERA with copies of
all material documents, information and correspondence received from any
Regulatory Authority and, only upon reasonable request, with copies of any other
documents, reports and communications from or to any Regulatory Authority
relating to Compound, Product and/or activities under this Agreement.  In
addition, ZENYAKU shall provide drafts of all proposed regulatory filings for
Product in the ZENYAKU Territory to ANTHERA for review and comment reasonably in
advance of submission to any Regulatory Authority in the ZENYAKU Territory to
enable ANTHERA to comment meaningfully thereon and ZENYAKU to consider such
comments. Except as may be provided in the safety data exchange agreement of
Section 4.8, ZENYAKU shall be responsible for the timely reporting of all
relevant adverse drug reactions/experiences, Product quality, Product complaints
and safety data relating to Compound and Product to the appropriate Regulatory
Authorities in the ZENYAKU Territory in accordance with all applicable laws,
rules and regulations.  ZENYAKU shall bear all costs and expenses incurred in
connection with its regulatory activities with respect to Compound and Product
in the Field in the ZENYAKU Territory.
 
(ii)         INDs for ANTHERA Trials in ZENYAKU Territory.  Notwithstanding
Section 4.7(a)(i), ANTHERA shall be responsible for the communications with
Regulatory Authorities in the ZENYAKU Territory in order to file and obtain
authorizations of INDs to permit the clinical trials of Product in the ZENYAKU
Territory that are provided for in the Joint Development Plan or approved in
writing by ZENYAKU, and for communications with Regulatory Authorities as to the
conduct of such trials.  ANTHERA shall coordinate closely with ZENYAKU in
advance regarding all such communications to ensure that ANTHERA’s
communications with Regulatory Authorities in the ZENYAKU Territory do not cause
confusion or otherwise harm ZENYAKU’s interactions with such Regulatory
Authorities relating to Compound and Product (whether telephonic or by other
electronic means or in person).  ZENYAKU shall have the right to be present
during any and all discussions between ANTHERA and the Regulatory Authorities of
the ZENYAKU Territory relating to Compound and Product.  ANTHERA shall promptly
provide ZENYAKU with copies of all documents, information and correspondence
received from any Regulatory Authority of the ZENYAKU Territory relating to
Compound, Product and/or activities under this Agreement.  In addition, ANTHERA
shall provide drafts of all proposed regulatory filings in relation to these
clinical trials for Compounds and Products for the Initial Indication and SLE in
the ZENYAKU Territory to ZENYAKU for review and comment reasonably in advance of
submission to any Regulatory Authority in the ZENYAKU Territory to enable
ZENYAKU to comment meaningfully thereon and ANTHERA to consider such comments.
 
(b)                   Access to Regulatory Filings.
 
(i)         ANTHERA shall promptly provide to ZENYAKU true and complete copies
of all B.L.A.s, DMFs, Regulatory Approvals and other filings and submissions to
Regulatory Authorities regarding Compound or Product in the Field in the ANTHERA
Territory, and hereby grants to ZENYAKU, without exception, the right to
cross-reference and access all such B.L.A.s, DMFs, Regulatory Approvals, filings
and submissions for the purposes of obtaining and maintaining Regulatory
Approvals for the Product in the ZENYAKU Territory and complying with applicable
pharmacovigilance and any other regulatory requirements relating to the Product
in the ZENYAKU Territory.
 
(ii)         ANTHERA shall, promptly upon request of ZENYAKU, file with
applicable Regulatory Authorities such letters of cross-reference and access as
may be necessary to accomplish the intent of this Section 4.7(b).
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
19.

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4.8           Pharmacovigilance
 
(a)                   Safety Data Exchange.  Prior to initiation of any clinical
trials under the ZENYAKU Development Plan, the parties shall negotiate in good
faith and enter into a safety data exchange agreement regarding Compound and
Product, which shall set forth standard operating procedures governing the
collection, investigation, reporting, and exchange of information concerning
adverse drug reactions/experiences sufficient to permit each party to comply
with its regulatory and other legal obligations within the applicable
timeframes.  Such agreement’s terms and conditions shall be no less stringent
than the ICH guidelines, such that each party shall be able to comply with all
regulatory and legal requirements regarding the management of safety data by
providing for the exchange of relevant information in appropriate format within
applicable timeframes.  Subject to the foregoing, each party shall be
responsible for monitoring all clinical experiences with respect to Products in
the course of its own Product development activities and filing all required
reports with respect thereto in its respective territory.  Compliance with the
safety data exchange agreement is an obligation under this Agreement.
 
(b)                   Other Licensees.  ANTHERA shall coordinate with its Other
Licensees for the exchange of safety data related to a Compound or Product.  If
such Other Licensees agree, the parties shall mutually cooperate to amend such
safety data exchange agreement to include such Other Licensees as they arise, so
that the global safety data exchange will be comprehensive.  If such Other
Licensees do not agree to enter into a safety data exchange agreement with
ZENYAKU as a party, ANTHERA will serve as the coordinating party for receipt of
any safety data or adverse event information received from such Other
Licensees.  ANTHERA shall ensure that no Other Licensee commences any clinical
trial of Compound or Product without becoming a party to a safety data exchange
agreement with ANTHERA allowing ANTHERA to share such safety data with ZENYAKU
on a timeline that allows ZENYAKU to comply with all applicable regulatory
requirements.
 
(c)                   Global Safety Database.  ANTHERA shall maintain the global
safety database for Product.
 
4.9           Cooperation of Employees and Consultants; Subcontracts.  Either
party may use subcontractors/contractors (including Third Party manufacturers or
contract manufacturers) and consultants in connection with any activity for
which it is responsible under this Agreement, provided that (a) none of the
other party’s rights hereunder are diminished or otherwise adversely affected as
a result of such use, and (b) the subcontractor/contractor or consultant
undertakes in writing obligations of confidentiality and restricted-use
regarding Confidential Information, the scope of which shall be at least as
stringent as the scope of ANTHERA’s and ZENYAKU’s obligations under Article 12,
provided however that a term of confidentiality protection of at least [***] in
confidential disclosure agreements between ANTHERA or ZENYAKU, as applicable,
and such subcontractors/contractors and consultants, shall be deemed to satisfy
the time requirement described in Section 12.1.  In the event a party performs
any of its activities hereunder through a subcontractor/contractor, then such
party shall at all times be fully responsible for the performance and payment of
such subcontractor/contractor or consultants.  Each party represents and agrees
that its employees, subcontractors/contractors (including without limitation
CMOs) and consultants shall be obligated under a binding written agreement to
assign or grant an exclusive license to the party, or as the party shall direct,
of all Product Know-How, Product Inventions and Product Patents conceived, made,
or reduced to practice by it during the course and as a result of performance
under this Agreement. ANTHERA and ZENYAKU agree to undertake to enforce
agreements with employees or others or rights pertaining to non-employees
(including, where appropriate, by legal action) considering, among other things,
the commercial value of the Product Know-How and Product Inventions.  This
Section shall not alter the requirements for what Patent and Know-How grant-back
rights a Party must use Commercially Reasonable Efforts to obtain from its
Sublicensee or Other Licensee as provided for elsewhere in this Agreement.
 
4.10           Records.  Each Party and its subcontractors/contractors shall
maintain complete and accurate records of all work conducted and all results,
Data, Inventions and developments made pursuant to its research and development
activities hereunder, including without limitation (a) scientific notebooks; and
(b) any other records that the other Party reasonably requests be retained to
ensure the preservation, prosecution, maintenance or enforcement of intellectual
property rights.  Such records shall be complete and accurate and shall fully
and properly reflect all work done and results achieved in the performance
hereof in sufficient detail and in good scientific manner appropriate for patent
and regulatory purposes.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
20.

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4.11           Third Party Agreements. During the Term, each party shall use
diligent efforts to maintain and not to breach any agreements with Third Parties
to the extent that they provide a grant of rights from such Third Party to a
party that are Controlled by such party and are licensed or become subject to a
license from such party to the other party under Article 2 or Article 13.  Each
party agrees to provide promptly the other party with notice of any such alleged
breach or obligation to renew.
 
4.12           Cooperation.  Each party shall use Commercially Reasonable
Efforts to provide the other party with all reasonable assistance and take all
actions reasonably requested by such other party, without changing the
allocation of responsibilities set forth in this Article 4, that are necessary
or desirable to enable the other party to obtain and maintain Regulatory
Approvals for Product in the Field in the other party’s territory.  Each party
further agrees to cooperate with any inspection by the FDA or other Regulatory
Authority relating to Product, including, but not limited to, any inspection
prior to approval of an application for Regulatory Approval for any Product.
 
4.13           Access to Data.
 
(a)           Each party shall promptly provide the other party with copies of
final reports and of all preclinical and clinical data, including Information
resulting from clinical trials and any other Information generated by such
party’s performance of any activities for the Initial Indication or SLE under
the Joint Development Plan, ZENYAKU Development Plan and/or ANTHERA Development
Plan as such reports and summaries become available to such party, and with
respect to any such data and Information for a Follow-On Indication other than
SLE, each party shall provide such data and Information as mutually agreed by
the parties pursuant to Section 7.4(b)(ii) (collectively, “Product Data”).
 
(b)           Each party hereby, compliant with all applicable laws, grants to
the other party, its Affiliates and sublicensees, with the right to use and
cross-reference any and all Product Data (subject to Section 7.4(b) with respect
to any Information for a Follow-On Indication) for the development and
commercialization of Products in such party’s territory.
 
(c)           Each party hereby acknowledges and understands that the other
party may license or sublicense (as the case may be) rights to the Products in
the Field to one or more Third Party licensees or sublicensees (i.e.,
Sublicensees and Other Licensees, as applicable) for development and
commercialization (each a “Third Party Partner”), and pursuant to such
arrangements, such party or such Third Party Partner shall generate additional
preclinical and clinical data and Information generated from such development
and commercialization of the Products (the “Third Party Data”).  Such party must
include in its contractual agreement(s) with such Third Party Partners the right
to transfer to the other party, its Affiliates and Third Party Partners such
Third Party Data, and the right for the other party, its Affiliates and Third
Party Partners to use and cross-reference, with the right to further sublicense
(through multiple tiers), such Third Party Data for Licensed Products in the
other party’s territory.
 
5.
Commercialization.

 
5.1           Subject to the terms and conditions of this Agreement, ZENYAKU
shall be solely responsible for the sale, marketing, promotion and
commercialization of Product in the Field in the ZENYAKU Territory, at ZENYAKU’s
sole expense. Upon Regulatory Approval of a Product in a country in the ZENYAKU
Territory, ZENYAKU shall use Commercially Reasonable Efforts to market, promote,
sell and commercialize such Product in such country.  In marketing, promoting
and commercializing Product in the Field in the ZENYAKU Territory, ZENYAKU shall
comply with all applicable laws, rules and regulations.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
21.

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6.
Manufacturing and Supply.

 
6.1           The parties shall use Commercially Reasonable Efforts to execute
(a) within [***]  after the Effective Date, a separate written supply agreement
for the supply by ANTHERA to ZENYAKU of clinical supplies of Compound and/or
Product (“Clinical Supply Agreement”), and (b) within [***] prior to the
anticipated date of completion of enrollment in the first Phase 3 Trial of
Product that will be used to submit the first B.L.A. for Product, a separate
written supply agreement for the supply by ANTHERA to ZENYAKU of commercial
supplies of Compound and/or Product, which may at ZENYAKU’s option be supplied
in bulk and/or filled and finished forms (“Commercial Supply Agreement”).  The
Clinical Supply Agreement and the Commercial Supply Agreement together are the
“Product Supply Agreement.”  The terms of the Product Supply Agreement shall be
consistent with this Article 6 and shall provide for ANTHERA to supply ZENYAKU’s
requirements of Compound and Product on terms consistent with this Agreement,
including Article 6.
 
6.2           The Product Supply Agreement will provide that the supply price of
Compound and Product supplied for use in clinical and registration activities in
the ZENYAKU Territory will equal ANTHERA’s Cost of Goods, and that the supply
price of Compound and Product for commercial sale shall be the sum of (a)
ANTHERA’s Cost of Goods plus [***] and (b) [***] (together, “Commercial Transfer
Price”). During the term of the Product Supply Agreement, no more frequently
than annually, the parties shall discuss whether to implement any changes to the
supply price of Compound and Product as a result of any change in circumstances,
including any reductions to NHI (National Health Insurance) price listing in
Japan, net of the amount of Japanese consumption tax upon Product sale (net of
such tax, the “NHI Pharmaceutical Product Price”), and including currency
fluctuation, to the extent such reductions or fluctuations may adversely affect
ZENYAKU’s margin on sales of Product in the ZENYAKU Territory.  Without limiting
the foregoing, the parties shall collaborate to identify alternative suppliers
for the manufacture of Compounds and Product, including bulk and finished
Product, with the purpose of reducing the supply price of such Compounds and
Products.  Notwithstanding anything express or implied:
 
(a)                   The Product Supply Agreement shall include a right for
ZENYAKU to practice its Manufacturing License granted under Section 2.1 to, or
engage a Third Party to, (a) manufacture Compound or Product in the event
ANTHERA fails to or will fail to timely supply ZENYAKU in accordance with the
then current Joint Development Plan or otherwise fails to supply in accordance
with the Product Supply Agreement, and (b) manufacture finished Product in the
event that ANTHERA’s supply of Product under such Product Supply Agreement is in
the form of Compound or bulk Product.  The Product Supply Agreement shall
contain other commercially reasonable terms and conditions to be negotiated in
good faith by the parties.  If ANTHERA becomes aware that it is reasonably
likely that ANTHERA will fail to timely supply ZENYAKU, ANTHERA shall promptly
notify ZENYAKU in writing and the parties will reasonably cooperate regarding
any reasonable measures that can be taken to avoid supply interruption to
ZENYAKU; and
 
(b)                   The Clinical Supply Agreement and Commercial Supply
Agreement shall each contain supply and ordering timelines and terms that are
reasonable and customary for clinical supply and commercial supply,
respectively.
 
6.3           Escrow for Cell Lines and Manufacturing Information.
 
(a)                   Promptly after the Effective Date, the Parties shall
establish within the possession of a Third Party (which may be ANTHERA’s Third
Party manufacturer if elected by ZENYAKU) (the “Escrow Agent”) an escrow for all
cell lines and other biological materials (including all of the types of
biological materials referred to in the Amgen Agreement) within the ANTHERA
Technology necessary to be able to manufacture Compound and Product (the “Cell
Line Escrow”) and a mechanism for release of such Cell Line Escrow from such
Escrow Agent to ZENYAKU pursuant to the written agreement between ZENYAKU, the
Escrow Agent, and ANTHERA referred to in Section 6.3(b). Such agreement shall
provide for release of the Cell Line Escrow to ZENYAKU in the circumstances in
which the Product Supply Agreement or this Agreement provides that ZENYAKU has
the right to practice the Manufacturing License.  ANTHERA shall update such Cell
Line Escrow quarterly with any and all additional cell lines or other such
biological materials used in the manufacture of Compound or Products.  To avoid
doubt, the “biological materials” referred to in this Section are only those
biological materials that are necessary to manufacture Compound and Product,
which are Controlled by ANTHERA.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
22.

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(b)                   Promptly after the Effective Date, the Parties shall
establish an escrow or escrows for Compound and Product manufacturing-related
Information and materials within the ANTHERA Technology (collectively, the
“Manufacturing Escrow”) under an escrow agreement between the parties and the
Escrow Agent.  This agreement would also govern the Cell Line Escrow.  ANTHERA
shall not unreasonably withhold its consent to a reasonable form of escrow
agreement for such purpose.  The Manufacturing Escrow shall be held by the
Escrow Agent, for release to ZENYAKU in the circumstances in which the Product
Supply Agreement or this Agreement provides that ZENYAKU has the right to
practice the Manufacturing License.  ZENYAKU shall be responsible for the
Manufacturing Escrow if the Escrow Agent elected by ZENYAKU is any Third Party
other than ANTHERA’s existing Third Party contract manufacturer.  Within [***]
after its establishment, ANTHERA shall deliver a plan to ZENYAKU in which the
Manufacturing Escrow will be deposited with the Escrow Agent, such Manufacturing
Escrow shall include complete master batch records and detailed protocols and
instructions for the manufacture, formulation, fill, and finish of Compound and
Product.  ANTHERA shall update such Manufacturing Escrow quarterly with any and
all changes.  In addition, ANTHERA shall fully cooperate in any technology
transfer under the terms of release provided in the Product Supply Agreement to
ZENYAKU’s chosen manufacturer that may be required, at ZENYAKU’s cost and
expense (including ANTHERA’s FTE costs and out-of-pocket costs (such FTE costs
to be at the FTE Rate and such out-of-pocket costs to be passed through at cost
with no mark-up).
 
6.4           In those circumstances in which ZENYAKU has the right to practice
the Manufacturing License, and ZENYAKU wishes to do so via a contract
manufacturer that is not on Amgen’s pre-approved list of contract manufacturers
in accordance with the Amgen Agreement, then ANTHERA shall facilitate obtaining
Amgen’s consent to ZENYAKU’s chosen manufacturer, and shall allow ZENYAKU to
confer directly with Amgen if need be.  If ZENYAKU chooses to manufacture for
itself, and any consent is required from Amgen under the Amgen Agreement, then
ANTHERA shall facilitate obtaining Amgen’s consent to ZENYAKU’s manufacture for
itself, and shall allow ZENYAKU to confer directly with Amgen if need be.  Other
than the foregoing restrictions relating to compliance with the Amgen Agreement,
ANTHERA shall have no right to approve ZENYAKU’s choice of contract manufacturer
nor ZENYAKU’s decision to be the manufacturer itself.  ZENYAKU’s use of such
Third Party manufacturer shall be subject to the terms and conditions of Section
4.9.
 
6.5           If parties are unable to agree on the terms of a Product Supply
Agreement within the 180 day period, or in such period as mutually agreed by the
parties, then the matter shall be resolved in accordance with Exhibit G.
 
7.
Fees, Payments and Equity Consideration

 
7.1           Upfront Loan. ZENYAKU shall provide a forgivable loan to ANTHERA
of Seven Million US Dollars (US$7,000,000) (the “Upfront Loan”) within five (5)
Japanese business days after the Escrow Agent confirms in writing to the Parties
under the written escrow agreement referred to in Section 6.3 that ANTHERA has
made the required deposits into the Cell Line Escrow in accordance with Article
6 (“Loan Date”).  The terms and conditions of the Upfront Loan are provided as
part of the Secured Promissory Note and the Security Agreement together attached
hereto as Exhibit D, which will be signed and delivered by the Parties as of the
Loan Date.  ANTHERA shall pledge  the Cell Line Escrow and the Manufacturing
Escrow as security for the Upfront Loan. Five Million Dollars ($5,000,000) of
the Upfront Loan shall be forgiven upon the statistically significant
achievement [***], if this occurs. The remaining Two Million Dollars
($2,000,000) of the Upfront Loan shall be forgiven upon submission of the first
B.L.A. for the Product in the ZENYAKU Territory, if this occurs.  Without
limiting the foregoing, the Upfront Loan shall be forgiven upon termination of
this Agreement, prior to the first dosing in the first Phase 3 Clinical Trial
for a Product that is initiated after the Effective Date of this Agreement,
pursuant to Section 13.2(c) thereof, either (x) in its entirety or (y) with
respect to Japan.  In addition to the rights and remedies provided for in the
loan documentation of Exhibit D, if ANTHERA defaults on the Upfront Loan, then
(a) ZENYAKU shall be released from all covenants not to make and have made
Compound and Product and to buy Compound and Product from ANTHERA; (b) ZENYAKU
shall be entitled to exercise the Manufacturing License to make and have made
Compound and Product (although ZENYAKU shall have the option to continue to
obtain supply of Compound and Product from ANTHERA if ZENYAKU chooses, and in
any event ANTHERA shall continue to supply ZENYAKU throughout a transition
period, if requested by ZENYAKU, until ZENYAKU is able to obtain supply from
another source, validated by the Regulatory Authorities having jurisdiction and
able to be used in clinical trials and for commercial sale in the Field); (c)
ZENYAKU shall be entitled to a technology transfer of manufacturing Information
necessary for the manufacture of Compound and Products in the Field in the
ZENYAKU Territory, including by release to ZENYAKU of all materials and
Information held in the Manufacturing Escrow (all of the foregoing at ANTHERA’s
sole cost); and (d) ZENYAKU will not owe ANTHERA any payment (other than paying
the Amgen Royalty on ZENYAKU and Sublicensee Net Sales directly to Amgen or any
Third Party Payments) with respect to quantities of Compound and Product that
ZENYAKU manufactures or obtains from another source.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
23.

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7.2           Milestone Payments.
 
(a)                   Development Milestones.  Within [***] after ZENYAKU
receives notice of achievement of each of Milestone Events 1 and 2 set forth
below, ZENYAKU shall pay to ANTHERA the corresponding non-refundable,
non-creditable milestone payment.
 
Milestone Events and Payments
 
1.           Five million Dollars ($5,000,000) for the first B.L.A. approval of
a Product in the ZENYAKU Territory.
 
2.           Two million dollars ($2,000,000) for the first B.L.A. approval of a
Product in the ZENYAKU Territory for the first Follow-On Indication (including
SLE) for which this occurs (this milestone event shall occur a maximum of once,
and shall not be due multiple times, even if multiple Follow-On Indications
receive B.L.A. approval).  To avoid doubt, sub-indications of the Indication
that achieved Milestone Event 1 shall not be considered Follow-On Indications
for purposes of this milestone event (nor, if a subindication of the Initial
Indication or SLE is the indication that achieved Milestone Event 1, shall the
approval of a second subindication of the Initial Indication or of SLE trigger
this Milestone Event 2 payment; rather, in that case, only the approval in the
ZENYAKU Territory of a B.L.A. for an Indication entirely outside of the Initial
Indication or SLE as applicable shall trigger this Milestone Event 2 payment.
 
The maximum amount payable under this Section 7.2(a) is seven million Dollars
($7,000,000).
 

(b)                   Sales Milestones.  Within 45 days after the end of the
first calendar year in which each of the milestone events set forth in the table
below is achieved, ZENYAKU shall pay to ANTHERA the corresponding
non-refundable, non-creditable milestone payment:
 
(i)         Japan.
 
Japan Sales Milestone Event
Payment (USD)
Aggregate Net Sales of all Products in Japan equal or exceed $150 million
$ 5 million
Aggregate Net Sales of all Products in Japan equal or exceed $250 million
$ 10 million
Total Possible Japan Sales Milestones
$15 million

 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
24.

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Each of the milestone payments set forth in Sections 7.2(b)(i) shall be payable
only one time, for the first achievement of the applicable milestone. Aggregate
Net Sales are measured beginning on first commercial sale of a Product, until
all Products are no longer being sold.
 
The maximum amount payable under this Section 7.2 is fifteen million Dollars
($15,000,000).
 

 
7.3           Equity Consideration.  Upon the Effective Date the parties are
entering into the Stock Purchase Agreement providing for certain rights and
obligations of the parties to purchase and sell Shares of ANTHERA, on the terms
and conditions and as provided for in more detail in such Stock Purchase
Agreement.
 
7.4           Development Expenses.
 
(a)                   Initial Indication.
 
(i)         Following the Effective Date, ANTHERA shall assume all Shared Costs
for the Initial Indication under the Joint Development Plan except as provided
in Section 7.4(a)(ii)(1).  In addition, Anthera shall assume [***]expenses for
the Product for the Initial Indication incurred by or under right from ANTHERA
within the ANTHERA Territory pursuant to the ANTHERA Development Plan.
 

 
(ii)         Following the Effective Date, ZENYAKU shall
 
(1)           reimburse to ANTHERA on a quarterly basis one hundred percent
(100%) of the Shared Costs in the ZENYAKU Territory under the Joint Development
Plan. In addition, ZENYAKU shall reimburse ANTHERA  [***] percent of the Shared
Cost in the ANTHERA Territory under the Joint Development Plan.  Such
reimbursement will be due thirty (30) days after the date of invoice from
ANTHERA. For clarity and solely as an example, if, as outlined in Exhibit C, the
Shared Costs for the Initial Indication incurred by or on behalf of ANTHERA
related to the clinical trial for the Initial Indication (i.e. the BRIGHT-SC
clinical trial) for a given quarter equal $[***] in the ANTHERA Territory, and
$[***] in the ZENYAKU Territory, the ZENYAKU reimbursement to ANTHERA would be
calculated as follows: (a) [***] for Shared Costs within the ANTHERA Territory,
plus (b) [***] for Shared Costs within the ZENYAKU Territory.  The total Shared
Costs reimbursement from ZENYAKU to ANTHERA for these activities in the quarter
would be $[***].  For the avoidance of doubt, ZENYAKU shall not be required to
reimburse ANTHERA for any expenses that would result in double-counting of
reimbursement for any individual patient expense.
 
(2)           assume one hundred percent (100%) of any clinical development
expenses for the Product for the Initial Indication incurred by or under right
from ZENYAKU within the ZENYAKU Territory pursuant to the ZENYAKU Development
Plan.
 
(3)           not be responsible for any Initial Indication development costs
for Products other than as specified in this Section 7.4(a)(ii).  Accounting for
Shared Costs shall be as provided for below in subsection (c).
 
(b)                   Follow-On Indications.
 
(i)         SLE.
 
(1)           ANTHERA shall assume all SLE Costs, except as provided in Section
7.4(b)(i)(2).  In addition, ANTHERA shall assume one-hundred percent (100%) of
any clinical development expenses for the Product for SLE incurred by or under
right from ANTHERA within the ANTHERA Territory pursuant to the ANTHERA
Development Plan.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
25.

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(2)           ZENYAKU shall reimburse to ANTHERA on a quarterly basis one
hundred percent (100%) of all SLE Costs directly attributable to patients
enrolled in the CHABLIS-SC2 Study in the ZENYAKU Territory under the Joint
Development Plan.  In addition, for any clinical development costs that are not
directly attributable to specific patients enrolled in the CHABLIS-SC2 Study,
but are specifically allocable to the conduct of the CHABLIS-SC2 Study under the
Joint Development Plan (for example and without limitation, such costs include
clinical trial database costs, lab set-up fees, data safety monitoring costs,
serious adverse event reporting systems, interactive voice response system, etc.
collectively, “Study Related Costs”), ZENYAKU will reimburse ANTHERA as
follows:  [***].  Such reimbursement will be due thirty (30) days after the date
of invoice from ANTHERA. [***]  For the avoidance of doubt, ZENYAKU shall not be
required to reimburse ANTHERA for any expenses that would result in
double-counting of reimbursement for any individual patient expense.
 
(3)           ZENYAKU shall assume one-hundred percent (100%) of any clinical
development expenses for the Product for SLE incurred by or under right from
ZENYAKU within the ZENYAKU Territory pursuant to the ZENYAKU Development Plan.
 
(ii)         Other Follow-On Indications.  For Follow-On Indications other than
SLE, the Parties shall discuss and agree on their respective roles and
responsibilities with regard to any cost-sharing or cooperative arrangement in
relation to such other Follow-On Indications.  Absent written agreement between
the Parties to the contrary:
 
(1)           Neither Party shall be required to reimburse the other as regards
costs of development for such other Follow-On Indications; and
 
(2)           Notwithstanding anything express or implied in this Agreement, the
Party that did not generate the data in such other Follow-On Indications shall
not have the right to use the efficacy data generated by the other Party in such
other Follow-On Indications, and shall not have the right to reference or access
such efficacy data.
 
(iii)         For the avoidance of doubt, this Section 7.4 shall not apply to
the sharing of information pursuant to Section 4.8 or any safety data exchange
agreement between the parties.   Safety data generated by or for a Party must be
freely shared between the Parties, even if generated in developing a Follow-On
Indication for which efficacy data from the same trial is not being shared
between the Parties.
 
(c)                   Accounting.
 
(i)         ANTHERA shall make quarterly reports of Shared Costs and SLE Costs
incurred in the calendar quarter to ZENYAKU and shall keep complete, full, and
accurate records of such costs.  Each such report shall be due within forty-five
(45) days after the end of the calendar quarter.  ZENYAKU shall be entitled to
cause such records to be audited.  In the case of Shared Costs, the audit as to
Shared Costs incurred in a calendar year shall occur, if at all, within three
(3) years after the end of that calendar year.  In the case of SLE Costs, the
audit as to SLE Costs shall occur, if at all, within three (3) years after
payment of any such costs to ANTHERA becomes due in accordance with this
Agreement.  For clarity, more detail regarding audits is set forth in Section
8.3(a).
 
(ii)         All internal resources and internal expenses of ANTHERA shall be
accounted for on and FTE basis, at the ANTHERA FTE Rate, and all overhead and
non-personnel internal resources of ANTHERA shall be considered included in the
ANTHERA FTE Rate.  For external costs, these shall be accounted for on a
pass-through, at-cost basis, with no markup.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
26.

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7.5           Existing Third Party Payment Obligations.
 
(a)                   ANTHERA shall be responsible for all license fee,
maintenance fee, royalty, milestone, sublicensing revenue or similar payment
obligations accruing with respect to the practice by ZENYAKU, its Affiliates and
Sublicensees of the ANTHERA Technology under any agreement between ANTHERA and a
Third Party entered into prior to the Effective Date.
 
(b)                   With respect to Net Sales of Products in the ZENYAKU
Territory by ZENYAKU, its Affiliates or Sublicensees, ZENYAKU shall pay to
ANTHERA the Amgen Royalty owed to Amgen during the Amgen Royalty Term pursuant
to the terms and conditions of the Amgen Agreement for the Net Sales of such
Products in the ZENYAKU Territory.
 
8.
Payment; Records; Audits

 
8.1           Exchange Rate; Manner and Place of Payment.  All payments
hereunder shall be payable in U.S. dollars.  When conversion of payments from
any foreign currency is required, such conversion shall be made at the exchange
rate used by ZENYAKU throughout its accounting system for conversion of such
currency during the calendar quarter for which a payment is due.  All payments
owed under this Agreement shall be made by wire transfer in immediately
available funds to a bank and account designated in writing by ANTHERA, unless
otherwise specified in writing by ANTHERA.  ANTHERA shall be responsible for any
bank transfer charges that result from the use of an intermediary bank in the
U.S.A.
 
8.2           Tax Withholding.
 
(a)                   ANTHERA shall be responsible for any and all taxes levied
on account of any payments made or otherwise due to ANTHERA under this
Agreement. If ZENYAKU is legally required to withhold any taxes from payments
made or otherwise due to ANTHERA hereunder, ZENYAKU shall (a) deduct such taxes
from the payment made to ANTHERA, (b) timely pay the U.S. taxes to the proper
taxing authority, and (c) send proof of payment to ANTHERA and certify its
receipt by the taxing authority [***] following such payment.
 
(b)                   ZENYAKU and ANTHERA will cooperate with respect to all
documentation required by any taxing authority or reasonably requested by
ANTHERA to secure a reduction in the rate of applicable taxes.
 
(c)                   Solely for purposes of this Section 8.2, “tax” or “taxes”
means any present or future taxes, levies, imposts, duties, charges, assessments
or fees of any nature (including interest, penalties and additions thereto) that
are imposed by the applicable government or other taxing authority.
 
8.3           Audits.
 
(a)                   Development Costs.  During the Term and for a period of
three years thereafter, ANTHERA shall keep, and shall cause its Affiliates
and  Other Licensees (solely to the extent such Other Licensees are conducting
activities under the Joint Development Plan) to keep, complete and accurate
records pertaining to all costs in connection with the development of Product by
or for ANTHERA or its Affiliates (including FTE records and records of external
expenditures) in sufficient detail to permit ZENYAKU to confirm the accuracy of
all shares of Shared Costs, SLE Costs and costs for any Follow-on Indication
other than SLE that may become due hereunder.  ZENYAKU shall have the right to
cause an independent, certified public accountant reasonably acceptable to
ANTHERA to audit such records to confirm such development costs and other
relevant information. Such audits may be exercised no more than once per year
during normal business hours upon reasonable prior written notice by
ZENYAKU.  The time frame for these audits is as stated in Section 7.4.  Such
records as to either Shared Costs or SLE Costs for a given year shall be subject
to audit hereunder only one time.  Prompt adjustments shall be made by the
parties to reflect the results of such audit.  ZENYAKU shall bear the full cost
of such audit unless such audit discloses a misreporting of Shared Costs or SLE
Costs by ANTHERA of more than [***] percent of Shared Costs or SLE Costs
(respectively) reported by ANTHERA, in which case, ANTHERA shall bear the full
cost of such audit and shall promptly remit to ZENYAKU the amount of any
overpayment by ZENYAKU that this may have caused.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
27.

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(b)                   Product Sales.  During the Term, ZENYAKU shall keep, and
shall cause its Affiliates and Sublicensees to keep, complete and accurate
records pertaining to the sale or other disposition of Products in sufficient
detail to permit ANTHERA to confirm the accuracy of all payments due
hereunder.  ANTHERA shall have the right to cause an independent, certified
public accountant reasonably acceptable to ZENYAKU to audit such records to
confirm Net Sales and other relevant information for a period covering not more
than the preceding three years. Such audits may be exercised no more than once
per year during normal business hours upon reasonable prior written notice to
ZENYAKU. Such records for a given year shall be subject to audit hereunder only
one time.  Prompt adjustments shall be made by the parties to reflect the
results of such audit.  ANTHERA shall bear the full cost of such audit unless
such audit discloses an underreporting by ZENYAKU of more than [***] percent of
the Net Sales for the entire period audited, in which case, ZENYAKU shall bear
the full cost of such audit and shall make any required milestone payment under
Section 7.2(b) to ANTHERA.  It is understood and agreed that the purpose of this
Section is to allow ANTHERA to verify if a Net Sales level milestone under
Section 7.2(b) has been reached.  No Net Sales royalties shall be due by ZENYAKU
under this Agreement.  ANTHERA’s right to audit under this Section 8.3(b) shall
expire upon ZENYAKU’s fulfillment of its obligations under Section 7.2(b) (i.e.,
at such time as both the milestones of that Section have come due (if they do)
and been fully paid to ANTHERA).
 
8.4           Late Payments.  In the event that any payment due under this
Agreement is not made when due, the payment shall accrue interest from the date
due [***]; provided, however, that in no event shall such rate exceed the
maximum legal annual interest rate.  The payment of such interest shall not
limit ANTHERA from exercising any other rights it may have as a consequence of
the lateness of any payment that is extraordinarily late, provided that such
lateness did not result from the payment being in dispute.
 
9.
Amgen Agreement.

 
9.1           Representations and Warranties of ANTHERA with respect to the
Amgen Agreement.  ANTHERA represents and warrants to ZENYAKU that, as of the
Effective Date:
 
(a)                   The Amgen Agreement is in full force and effect and has
not been modified or amended, except as provided in the written amendments
provided to ZENYAKU prior to the Effective Date;
 
(b)                   Under the Amgen Agreement, as amended, [***];
 
(c)                   Under the Amgen Agreement, as amended in the written
amendments provided to ZENYAKU prior to the Effective Date, the royalty due
[***] percent.
 
(d)                   ANTHERA is not aware of [***]by ANTHERA to Amgen with
respect to the ZENYAKU Territory;
 
(e)                   Neither ANTHERA nor, to the best of ANTHERA’s knowledge
and belief, Amgen is in default with respect to any obligation under, and
neither such party has claimed or has grounds upon which to claim that the other
party is in default with respect to any obligation under, the Amgen Agreement;
 
(f)                   To the best of ANTHERA’s knowledge and belief, the rights
that Amgen has licensed to ANTHERA pursuant to the Amgen Agreement were not and
are not subject to any restrictions or limitations except as set forth in the
Amgen Agreement;
 
(g)                   ANTHERA has not waived or allowed to lapse any of its
rights to the Product nor to any related Information or Patents in the ZENYAKU
Territory under the Amgen Agreement, and no such rights have lapsed or otherwise
expired or been terminated;
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
28.

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(h)                   ANTHERA has not received any notice of breach under the
Amgen Agreement, and knows of no reason based on facts currently existing that
could serve as the basis for such a breach notice;
 
(i)                   This Agreement is in compliance with the Amgen Agreement
and ANTHERA’s execution and performance of this Agreement in accordance with the
terms hereof shall not in any way breach the Amgen Agreement, ignoring the
impact of Section 9.3.
 
9.2           ANTHERA Obligations with respect to the Amgen Agreement.  ANTHERA
agrees that during the Term:
 
(a)                   ANTHERA shall fulfill all of its obligations under the
Amgen Agreement (including, without limitation, the payment of all consideration
under Article 4 thereof), to the extent that failure to do so would adversely
affect ZENYAKU or its rights hereunder and such failure is not due to any breach
of this Agreement by ZENYAKU;
 
(b)                   ANTHERA shall not enter into any subsequent agreement with
Amgen that modifies or amends the Amgen Agreement in any way that might
adversely affect ZENYAKU’s rights under this Agreement without ZENYAKU’s prior
written consent, and shall provide ZENYAKU with a copy of all proposed
modifications to or amendments of the Amgen Agreement prior to agreeing to them,
regardless of whether ZENYAKU’s consent was required with respect thereto;
 
(c)                   ANTHERA shall not terminate, nor take or fail to take any
action that would or could reasonably be expected to terminate, the Amgen
Agreement in whole or in part, directly or indirectly, without ZENYAKU’s prior
written consent;
 
(d)                   ANTHERA shall furnish ZENYAKU with copies of all notices
received by ANTHERA relating to any alleged breach or default of any obligation
by ANTHERA under the Amgen Agreement within three business days after ANTHERA’s
receipt thereof.
 
9.3           ZENYAKU Obligations with respect to Amgen Agreement.  ZENYAKU
acknowledges and agrees that the licenses granted by ANTHERA pursuant to Section
2.1 include sublicenses to Information and Patents that have been licensed to
ANTHERA under the Amgen Agreement, and that such sublicenses are subject to the
terms and conditions of the Amgen Agreement.  During the Term, ZENYAKU and its
Affiliates hereby agrees to, and to ensure that its Sublicensees, comply with
all applicable terms and conditions of the Amgen Agreement with respect to the
Field and the ZENYAKU Territory.  ZENYAKU covenants not to take or fail to take
any action that violates a term of the Amgen Agreement applicable to ZENYAKU as
a sublicensee of ANTHERA under such Amgen Agreement, or that would cause ANTHERA
to be in breach of any of the terms of the Amgen Agreement.
 
9.4           Termination of Amgen Agreement.  In the event that the Amgen
Agreement is terminated by Amgen or ANTHERA for any reason, then, as of the
effective termination date of such termination, upon the election of ZENYAKU,
ZENYAKU automatically shall become a direct licensee of Amgen under rights and
terms equivalent to those contained in this Agreement with respect to the rights
sublicensed by ANTHERA to ZENYAKU under Section 2.1 without any further consent
of either ANTHERA or Amgen being required (an “Amgen Direct License”); provided
that (a) ZENYAKU is not in material breach of the terms and conditions of this
Agreement or, if applicable, the Amgen Agreement and (b) ZENYAKU agrees to
assume all of ANTHERA’s future obligations (i.e., obligations after becoming
such direct licensee) under the Amgen Agreement with respect to the rights
sublicensed by ANTHERA to ZENYAKU (including the territory, field of use, and
products), to the extent relating to the activities of ZENYAKU.  To avoid doubt,
if ZENYAKU is required to make any payment(s) under the Amgen Direct License
that would not have been required to be paid by ZENYAKU under this Agreement
(including any milestone payment to Amgen) with respect to the rights
sublicensed under the Amgen Agreement by ANTHERA to ZENYAKU, the amount of such
payment(s) actually paid by ZENYAKU to Amgen shall be credited against any
amounts payable by ZENYAKU under this Agreement, without limiting ZENYAKU’s
rights to recover its damages under this Agreement to the extent exceeding the
amount of such credit (for non-limiting example, in the case in which the
payments to Amgen exceed payments to ANTHERA that would otherwise be required in
accordance with this Agreement).
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
29.

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10.
Intellectual Property

 
10.1           Ownership of Inventions.  Inventorship of Inventions shall be
determined in accordance with the rules of inventorship under U.S. patent
laws.  As between the parties, ANTHERA shall solely own all ANTHERA
Inventions.  As between the parties, ZENYAKU shall solely own all ZENYAKU
Inventions.  As between the parties, the parties shall jointly own all Joint
Inventions.  A party shall be entitled to license or sell its interest in any of
the foregoing, provided that the license and other rights of the other party to
this Agreement are maintained in full force and effect both before and after
such licensing or sale.
 
10.2           Patent Prosecution and Maintenance.
 
(a)                   ANTHERA Patents.  As between the parties, ANTHERA shall
have the sole right, but not the obligation, to control and manage the
preparation, filing, prosecution (including any interferences, reissue
proceedings and reexaminations) and maintenance of all ANTHERA Patents in the
ANTHERA Territory, at its sole cost and expense and by counsel of its own
choice.  As between the parties, ANTHERA shall have the first right to control
and manage the preparation, filing, prosecution (including any interferences,
reissue proceedings and reexaminations) and maintenance of all ANTHERA Patents
in the ZENYAKU Territory by counsel of ANTHERA’s choosing.  ZENYAKU shall
reimburse ANTHERA for all out-of-pocket costs paid by ANTHERA for the activities
of the foregoing sentence (but not the costs of the activities of the first
sentence of this Section).  ANTHERA shall keep ZENYAKU reasonably informed (in
any event, at least 45 days in advance of any deadline or submission) of
progress with regard to the preparation, filing, prosecution and maintenance of
ANTHERA Patents in the ZENYAKU Territory.  ZENYAKU shall have a right to comment
on such filings in the ZENYAKU territory, using counsel of ZENYAKU’s choosing,
and shall bear the costs of the attorney(s) engaged by ZENYAKU. The parties
shall consult with each other, and consider in good faith the requests and
suggestions of, each other, with respect to strategies for filing and
prosecuting ANTHERA Patents and the prosecuting party shall implement the
reasonable requests and suggestions of the other with respect to the
preparation, filing, prosecution (including any interferences, reissue
proceedings and reexaminations) and maintenance of all ANTHERA Patents in the
ZENYAKU Territory and shall promptly provide copies of all office actions and
drafts of proposed filings to enable the foregoing.  In the event that ANTHERA
desires to abandon or cease prosecution or maintenance of any ANTHERA Patent in
the ZENYAKU Territory, ANTHERA shall provide reasonable prior written notice to
ZENYAKU of such intention to abandon (which notice shall, to the extent
possible, be given no later than 45 days prior to the next deadline for any
action that must be taken with respect to any such ANTHERA Patent in the
relevant patent office).  In such case, and at ZENYAKU’s sole discretion, upon
written notice to ANTHERA from ZENYAKU, ZENYAKU may elect to continue
prosecution and/or maintenance of any such ANTHERA Patent, at its sole cost and
expense and by counsel of its own choice. Without limiting the generality of the
foregoing, ANTHERA shall reasonably cooperate with ZENYAKU to extend the term of
any ANTHERA Patent in the ZENYAKU Territory that ZENYAKU requests.  Each party
shall bear its own costs in connection with such extension.
 
(b)                   Joint Patents.  ANTHERA shall have the first right, but
not the obligation, to control and manage the preparation, filing, prosecution
(including any interferences, reissue proceedings and reexaminations) and
maintenance of all Joint Patents in the ANTHERA Territory, at its sole cost and
expense and by counsel of its own choice.  ZENYAKU shall have the first right,
but not the obligation, to control and manage the preparation, filing,
prosecution (including any interferences, reissue proceedings and
reexaminations) and maintenance of all Joint Patents in the ZENYAKU Territory,
at its sole cost and expense and by counsel of its own choice.  Each party shall
keep the other party reasonably informed of progress with regard to the
preparation, filing, prosecution and maintenance of Joint Patents for which such
party (the “Responsible Party”) is responsible, and shall consult with, and
consider in good faith the requests and suggestions of, the other party with
respect to strategies for filing and prosecuting Joint Patents worldwide.  In
the event that the Responsible Party desires to abandon or cease prosecution or
maintenance of any Joint Patent in any country, the Responsible Party shall
provide reasonable prior written notice to the other party of such intention to
abandon (which notice shall, to the extent possible, be given no later than
45 days prior to the next deadline for any action that must be taken with
respect to any such Joint Patent in the relevant patent office).  In such case,
at the other party’s sole discretion, upon written notice to the Responsible
Party from the other party, the other party may elect to continue prosecution
and/or maintenance of any such Joint Patent, at its sole cost and expense and by
counsel of its own choice.  In this case, the Responsible Party shall not be
under any obligation to assign all of its right, title and interest in and to
such Joint Patent to the other Party.  The nature of joint ownership of the
Joint Patents shall be undivided one half interests, equivalent to the ownership
interests of co-inventors under U.S. patent law, to the maximum extent
achievable by contract throughout the world, and each party hereby grants any
and all licenses, permission, and waivers not at odds with the remainder of this
Agreement to achieve such rights of joint owners.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
30.

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(c)                   ZENYAKU Patents.  ZENYAKU shall have the sole right, but
not the obligation, to control and manage the preparation, filing, prosecution
(including any interferences, reissue proceedings and reexaminations) and
maintenance of all ZENYAKU Patents in the ZENYAKU Territory, at its sole cost
and expense and by counsel of its own choice.  ZENYAKU shall have the first
right, but not the obligation, to control and manage the preparation, filing,
prosecution (including any interferences, reissue proceedings and
reexaminations) and maintenance of all ZENYAKU Patents in the ANTHERA Territory,
by counsel of its own choice. ZENYAKU shall keep ANTHERA reasonably informed of
progress with regard to the preparation, filing, prosecution and maintenance of
ZENYAKU Patents in the ANTHERA Territory. In the event that ZENYAKU desires to
abandon or cease prosecution or maintenance of any ZENYAKU Patent in the ZENYAKU
Territory or the ANTHERA Territory, ZENYAKU shall provide reasonable prior
written notice to ANTHERA of such intention to abandon (which notice shall, to
the extent possible, be given no later than 45 days prior to the next deadline
for any action that must be taken with respect to any such ZENYAKU Patent in the
relevant patent office).  In such case, at ANTHERA’s sole discretion, upon
written notice to ZENYAKU from ANTHERA, ANTHERA may elect to continue
prosecution and/or maintenance of any such ZENYAKU Patent, at its sole cost and
expense and by counsel of its own choice.
 
10.3           Cooperation of the Parties.  Each party agrees to cooperate fully
in the preparation, filing, prosecution and maintenance of Patents under
Section 10.2 and in the obtaining and maintenance of any patent extensions,
supplementary protection certificates and the like with respect thereto.  Such
cooperation includes, but is not limited to: (a) executing all papers and
instruments, or requiring its employees or contractors, to execute such papers
and instruments, so as to effectuate the ownership of Inventions set forth in
Section 10.1, and Patents claiming or disclosing such Inventions, and to enable
the other party to apply for and to prosecute patent applications in any country
as permitted by Section 10.2; and (b) promptly informing the other party of any
matters coming to such party’s attention that may affect the preparation,
filing, prosecution or maintenance of any such patent applications.
 
10.4           Infringement by Third Parties.
 
(a)                   Notice.  In the event that either ANTHERA or ZENYAKU
becomes aware of any infringement or threatened infringement by a Third Party of
any ANTHERA Patents, ZENYAKU Patents or Joint Patents, it shall notify the other
party in writing to that effect.
 
(b)                   ANTHERA Patents.
 
(i)         ZENYAKU shall have the first right to bring and control any action
or proceeding against a Third Party with respect to infringement (including
patent invalidation and nullity actions) of any ANTHERA Patent in the Field in
the ZENYAKU Territory, where the infringing activity involves a Compound,
Product, or Competing Product, at its own expense and by counsel of its own
choice, and ANTHERA shall have the right, at its own expense, to be represented
in any such action by counsel of its own choice. If ZENYAKU fails to bring any
such action or proceeding within (A) [***] (in the case of ANTHERA Patents other
than Amgen Patents) and [***] (in the case of Amgen Patents), in each case
following the notice of alleged infringement, or (B) [***] before the time
limit, if any, set forth in the appropriate laws and regulations for the filing
of such actions, whichever comes first, then ANTHERA (or Amgen solely with
respect to the Amgen Patents) shall have the right to bring and control any such
action, at its own expense and by counsel of its own choice, and ZENYAKU shall
have the right, at its own expense, to be represented in any such action by
counsel of its own choice.  With respect to the Amgen Patents only, if Amgen
does not exercise its back-up right, then ZENYAKU shall have an additional [***]
to exercise its first right in the ZENYAKU Territory as between it and ANTHERA,
and thereafter ANTHERA shall have the back-up right. Each Party shall take
appropriate actions, including executing any documents required by applicable
law, in order to enable the enforcing Party to commence a suit or take the
actions set forth in this Section 10.4(b).
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
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(ii)         ANTHERA shall have the sole right to bring and control any action
or proceeding with respect to infringement of any ANTHERA Patent: (A) in the
ZENYAKU Territory with respect to any infringing activity that is outside the
Field or that does not involve a Compound, Product, or Competing Product;
provided however that ANTHERA shall coordinate with ZENYAKU strategies for
invalidity defenses which are part of any infringement action in the ZENYAKU
Territory and shall implement the reasonable requests and suggestions that
ZENYAKU makes in that respect to protect ZENYAKU’s rights hereunder and (B) in
the ANTHERA Territory; in each case, at its own expense and by counsel of its
own choice.
 
(c)                   Joint Patents.
 
(i)         ZENYAKU shall have the first right to bring and control any action
or proceeding with respect to infringement (including patent invalidation and
nullity actions) of any Joint Patent in the Field in the ZENYAKU Territory where
the infringing activity involves a Compound, Product, or Competing Product, at
its own expense and by counsel of its own choice, and ANTHERA shall have the
right, at its own expense, to be represented in any such action by counsel of
its own choice.  ANTHERA shall have the first right to bring and control any
action or proceeding with respect to infringement of any Joint Patent in the
Field in the ANTHERA Territory where the infringing activity involves a
Compound, Product, or Competing Product, at its own expense and by counsel of
its own choice, and ZENYAKU shall have the right, at its own expense, to be
represented in any such action by counsel of its own choice.  If the party with
the first right to bring and control any such action or proceeding fails to do
so within (A) [***] following the notice of alleged infringement, or (B) [***]
before the time limit, if any, set forth in the appropriate laws and regulations
for the filing of such actions, whichever comes first, then the other party
shall have the right to bring and control any such action, at its own expense
and by counsel of its own choice, and the first party shall have the right, at
its own expense, to be represented in any such action by counsel of its own
choice.
 
(ii)         With respect to any infringement of a Joint Patent by infringing
activity other than that described in Section 10.4(c)(i), the parties shall
mutually agree on a case-by-case basis whether to initiate and prosecute any
legal action to enforce any such Joint Patent and, if the parties agree to
initiate and prosecute any such action, which party will be responsible for
initiating and prosecuting such action, and how costs and recoveries will be
allocated between the parties.
 
(d)                   ZENYAKU Patents.
 
(i)         For ZENYAKU Patents that do not Cover any compound or product other
than Compound and Product, ANTHERA shall have the first right to bring and
control any action or proceeding against a Third Party with respect to
infringement of any ZENYAKU Patent in the Field in the ANTHERA Territory, at its
own expense and by counsel of its own choice, and ZENYAKU shall have the right,
at its own expense, to be represented in any such action by counsel of its own
choice.  If ANTHERA fails to bring any such action or proceeding within
(A) [***] following the notice of alleged infringement, or (B) [***] before the
time limit, if any, set forth in the appropriate laws and regulations for the
filing of such actions, whichever comes first, then ZENYAKU shall have the right
to bring and control any such action, at its own expense and by counsel of its
own choice, and ANTHERA shall have the right, at its own expense, to be
represented in any such action by counsel of its own choice.
 
(ii)         ZENYAKU shall have the sole right to bring and control any action
or proceeding with respect to infringement (including patent invalidation and
nullity actions) of any ZENYAKU Patent: (A) respect to any infringing activity
that does not involve a Compound or Product in the Field in the ANTHERA
Territory; and (B) in the ZENYAKU Territory; in each case, at its own expense
and by counsel of its own choice.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
32.

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(e)                   Cooperation; Award; Damages.  In the event a party brings
an infringement action in accordance with this Section 10.4, the other party
shall cooperate fully, including, if required to bring such action, the
furnishing of a power of attorney or being named as a party.  Neither party
shall enter into any settlement or compromise of any action under this
Section 10.4 which would in any manner alter, diminish, or be in derogation of
the other party’s rights under this Agreement without the prior written consent
of such other party, which, shall not be unreasonably withheld.  Except as
otherwise agreed by the parties in connection with a cost-sharing arrangement,
any recovery realized by a party as a result of any action or proceeding
pursuant to this Section 10.4, whether by way of settlement or otherwise, after
reimbursement of any litigation expenses of the parties, shall be retained by
the party that brought and controlled such action for purposes of this
Agreement; provided, however, that any recovery realized by ZENYAKU as a result
of any action pursuant to Section 10.4(b) or Section 10.4(c) (after
reimbursement of the parties’ litigation expenses) with respect to infringing
activity in the ZENYAKU Territory that involves a compound or product that is
competitive with a Compound or Product being developed or commercialized by or
on behalf of ZENYAKU, its Affiliate or a Sublicensee in the ZENYAKU Territory,
shall be treated as Net Sales of Products by ZENYAKU (i.e., for the purposes of
the milestones of Section 7.2(b)).
 
10.5           Infringement of Third Party Rights.  Each party shall promptly
notify the other in writing of any allegation by a Third Party that the activity
of either of the parties pursuant to this Agreement infringes or may infringe
the intellectual property rights of such Third Party.  ANTHERA shall have the
sole right to control any defense of any such claim involving alleged
infringement of Third Party rights by ANTHERA’s activities at its own expense
and by counsel of its own choice, and ZENYAKU shall have the right, at its own
expense, to be represented in any such action by counsel of its own
choice.  ZENYAKU shall have the sole right to control any defense of any such
claim involving alleged infringement of Third Party rights by ZENYAKU’s
activities at its own expense and by counsel of its own choice, and ANTHERA
shall have the right, at its own expense, to be represented in any such action
by counsel of its own choice.  Neither party shall have the right to settle any
patent infringement litigation under this Section 10.5 in a manner that
diminishes the rights or interests of the other party without the written
consent of such other party (which shall not be unreasonably withheld).
 
10.6           Trademarks.
 
(a)                   Product Marks.  The parties shall, via the JDC, closely
coordinate with respect to the selection and use of Product-specific trademarks
in the parties’ respective territories (“Product Marks”), provided that:
(i) ANTHERA shall have the sole right to select the Product Trademarks for use
in connection with the marketing and sale of Product in the ANTHERA Territory
(“ANTHERA Product Marks”), and ANTHERA shall own and retain all right, title and
interest in and to the ANTHERA Product Marks, and all goodwill associated with
or attached to the ANTHERA Product Marks arising out of the use thereof by
ANTHERA, its Affiliates and Third Party licensees shall inure to the benefit of
ANTHERA; and (ii) ZENYAKU shall have the sole right to select the Product
Trademarks for use in connection with the marketing and sale of Product in the
ZENYAKU Territory (“ZENYAKU Product Marks”), and ZENYAKU shall own and retain
all right, title and interest in and to the ZENYAKU Product Marks, and all
goodwill associated with or attached to the ZENYAKU Product Marks arising out of
the use thereof by ZENYAKU, its Affiliates and Sublicensees shall inure to the
benefit of ZENYAKU. Notwithstanding the foregoing, neither party shall select as
a Product Mark any trademark that incorporates, or is confusingly similar to,
any corporate trade name, registered trademark or logo of the other party,
without the other party’s prior written approval. If the parties wish to use the
same or similar Product Mark in the ANTHERA Territory and the ZENYAKU Territory,
any such use shall be on terms and conditions to be mutually agreed by the
parties in writing, provided however that the parties hereby agree that each
party shall be the owner of the selected Product Mark in its respective
territory and bear the costs and expenses associated with the registration,
maintenance and defence of such Product Mark in its territory.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
33.

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(b)                   ANTHERA Corporate Marks.  Except to the extent prohibited
by applicable law in the ZENYAKU Territory, or otherwise directed by ANTHERA in
writing, all packaging, labeling, advertising and promotional material used by
ZENYAKU, its Affiliates and Sublicensees in connection with any Product, shall
feature ANTHERA’s corporate trade name and logo (“ANTHERA Corporate Marks”).
Subject to the terms and conditions of this Agreement, ANTHERA hereby grants to
ZENYAKU a non-exclusive, royalty-free license, with the right to sublicense to
an Affiliate or Sublicensee to whom ZENYAKU grants a sublicense under the
Exclusive License or any portion thereof, to use the ANTHERA Corporate Marks
solely in connection with the use, sale, importation, distribution and marketing
of the Product in the Field in the ZENYAKU Territory, including the use of the
ANTHERA Corporate Marks on Product packaging, labeling, advertising and
promotional material. ANTHERA or an Affiliate of ANTHERA shall retain the
ownership of the entire right, title and interest in and to the ANTHERA
Corporate Marks. All goodwill associated with or attached to the ANTHERA
Corporate Marks arising out of the use thereof by ZENYAKU, its Affiliates and
Sublicensees shall inure to the benefit of ANTHERA.  ZENYAKU agrees not to
contest, oppose or challenge ANTHERA’s ownership of the ANTHERA Corporate
Marks.  ZENYAKU agrees not to do or suffer to be done, at any time, any act or
thing that will in any way impair ANTHERA’s ownership of or rights in and to the
ANTHERA Corporate Marks or any registration thereof or that may depreciate the
value of the ANTHERA Corporate Marks or the reputation of ANTHERA.  ZENYAKU
agrees that in using ANTHERA Corporate Marks upon any Product packaging,
labeling, advertising or promotional materials, it shall not represent in any
way that it has any right or title to the ownership of the ANTHERA Corporate
Marks or the registration thereof. ZENYAKU shall obtain the prior written
approval of ANTHERA of the form and manner in which the ANTHERA Corporate Marks
will be used upon, in connection with, or in relation to, the Products, or any
packaging, labels, containers, advertisements and other materials related
thereto; provided that ANTHERA shall not unreasonably withhold such consent and
in any event ZENYAKU shall be entitled to use and display ANTHERA’s name where
required by local law or regulation.  Wherever any ANTHERA Corporate Mark is
used, e.g., on any package, label or advertisement, the first or most prominent
use shall always be accompanied by a legend indicating that the Product is under
license from or utilizes the proprietary technology of or is supplied by
ANTHERA.  ZENYAKU shall, at ANTHERA’s request and expense, assist ANTHERA in any
action reasonably necessary or desirable to protect the ANTHERA Corporate Marks
used or proposed to be used hereunder, at ANTHERA’s expense.  ZENYAKU shall as
soon as practicable notify ANTHERA of any apparent infringement by a Third Party
of any of the ANTHERA Corporate Marks.  ZENYAKU agrees to cooperate with ANTHERA
to enable ANTHERA to control the nature and quality of the use of the ANTHERA
Corporate Marks such that ANTHERA may verify that the use of the ANTHERA
Corporate Marks is consistent with ANTHERA’s quality standards and Product
specifications.  Notwithstanding anything express or implied in this Section:
(a) ZENYAKU is not required to make any use of any ANTHERA Corporate Mark nor
include any text in the packaging, labeling, advertising and promotional
material for Product, if such use would be contrary to law or commercially
unreasonable; and (b) ZENYAKU shall be required to include ANTHERA Corporate
Marks on only those items of packaging, labeling, advertising and promotional
material for Product, and in a size and prominence, that the parties have
mutually agreed.
 
10.7           Third Party Rights.  To the extent that a Third Party licensor of
ANTHERA has retained any right to prosecute or enforce any ANTHERA Patents or
otherwise be involved in such activities (including the right to decide on
matters related to patent term extensions)  pursuant to an agreement granting
ANTHERA a license thereto (including with respect to the Amgen Patents pursuant
to the Amgen Agreement), ANTHERA will use commercially reasonable efforts to
cause such Third Party licensor to take the actions (or refrain from taking
action, as applicable) consistent with this Article 10.  Notwithstanding the
foregoing, ANTHERA will not be deemed to be in breach of its obligations under
this Article 10 if, after using such commercially reasonable efforts, it is
unable to comply with such obligations because of actions taken or not taken by
such Third Party licensor.
 
11.
Representations and Warranties

 
11.1           Mutual Representations and Warranties.  Each party represents and
warrants to the other that: (a) it is duly organized and validly existing under
the laws of its jurisdiction of incorporation or formation, and has full
corporate or other power and authority to enter into this Agreement and to carry
out the provisions hereof; (b) it is duly authorized to execute and deliver this
Agreement and to perform its obligations hereunder, and the person or persons
executing this Agreement on its behalf has been duly authorized to do so by all
requisite corporate or partnership action; and (c) this Agreement is legally
binding upon it, enforceable in accordance with its terms, and does not conflict
with any agreement, instrument or understanding, oral or written, to which it is
a party or by which it may be bound, nor violate any material law or regulation
of any court, governmental body or administrative or other agency having
jurisdiction over it.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
34.

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11.2            ANTHERA Representations and Warranties.  As a material
inducement for ZENYAKU to enter into this Agreement, it being acknowledged that
the representations and warranties in this Section 11.2 constitute a material
component of the basis on which ZENYAKU is prepared execute and deliver this
Agreement, ANTHERA represents and warrants to ZENYAKU that, as of the Effective
Date:
 
(a)                   ANTHERA has not granted to any Third Party any license or
other right with respect to Compound, Products or ANTHERA Technology that
conflicts with the rights granted to ZENYAKU herein;
 
(b)                   other than the Amgen Agreement, there are no agreements in
effect as of the Effective Date between ANTHERA and a Third Party under which
rights with respect to the ANTHERA Technology are being licensed to ANTHERA;
 
(c)                   ANTHERA is the sole and exclusive owner of all right,
title and interest in and to the ANTHERA Patents in existence on the Effective
Date, other than the ANTHERA Patents licensed to ANTHERA pursuant to the Amgen
Agreement;
 
(d)                   ANTHERA (i) has obtained the assignment of all interests
and all rights of its employees with respect to the ANTHERA Know-How and ANTHERA
Patents other than the ANTHERA Patents licensed to ANTHERA pursuant to the Amgen
Agreement, (ii) has obtained the assignment of all interests and all rights of
any and all other Third Parties with respect to the ANTHERA Know-How and ANTHERA
Patents other than the ANTHERA Patents licensed to ANTHERA pursuant to the Amgen
Agreement, and (iii) has taken reasonable measures to protect the
confidentiality of the ANTHERA Know-How;
 
(e)                   ANTHERA has the right to license and disclose the ANTHERA
Know-How to ZENYAKU as contemplated by this Agreement and ANTHERA Know-How was
not obtained by ANTHERA in violation of any contractual or fiduciary obligation
to which ANTHERA or any of its employees or staff members are or were bound, or
by the misappropriation of the trade secrets of any Third Party;
 
(f)                   To the best of ANTHERA’s knowledge, there is no use,
infringement or misappropriation of the ANTHERA Technology in derogation of the
rights granted to ZENYAKU in this Agreement;
 
(g)                   Exhibit B attached hereto accurately and completely
identifies all ANTHERA Patents as of the Effective Date;
 
(h)                   Each ANTHERA Patent listed in Exhibit B hereto, has been
prosecuted in compliance in all material respects with all applicable rules,
policies and procedures of the jurisdiction in which such ANTHERA Patent was
filed and is subsisting and in good standing. ANTHERA is not aware of any prior
art or other facts that were required to be disclosed in the prosecution of the
ANTHERA Patents but were not disclosed as required, or that otherwise may render
the ANTHERA Patents unpatentable, invalid or unenforceable. All renewal and
maintenance fees due as of the Effective Date with respect to the prosecution
and maintenance of the ANTHERA Patents have been paid;
 
(i)                   ANTHERA has not received written notice from any Third
Party claiming that the manufacture, use, sale, offer for sale or import of any
Compound or Product infringes or would infringe the patent or other intellectual
property rights of any Third Party;
 
(j)                   To the best of ANTHERA’s knowledge and belief, the
practice of ANTHERA Patents as practiced by ANTHERA as of the Effective Date
does not and the practice of the ANTHERA Patents as contemplated by this
Agreement shall not infringe upon or conflict with any Patent or other
intellectual property right of any Third Party;
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
35.

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(k)                   ANTHERA is not a party to any legal action, suit or
proceeding relating to the ANTHERA Technology or any Compound or Product, nor
has ANTHERA received any written communication from any Third Party, including,
without limitation, any Regulatory Authority or other government agency,
threatening such action, suit or proceeding;
 
(l)                   The research and development of the Compounds and Products
prior to the Effective Date by ANTHERA and its Affiliates and, to the knowledge
of ANTHERA, its independent contractors, was conducted in compliance, in all
material respects, with all applicable laws and regulations, including all
public health, environmental and safety provisions thereof;
 
(m)                   In the course of the development of the Products, ANTHERA
has not used any employee, consultant, agent or advisor who has been debarred by
any Regulatory Authority, or to the best of ANTHERA’s knowledge, is the subject
of debarment proceedings by a Regulatory Authority;
 
(n)                   ANTHERA has made available to ZENYAKU for its review all
Data Controlled by ANTHERA as of the Effective Date with respect to Compound
and/or Products, including all data from clinical trials of Product the Initial
Indication as well as all written agreements (and amendments thereto) between
ANTHERA and Amgen relating to Compound and/or Product, and all Patent-related
information known to ANTHERA related to Compound and/or Product;
 
(o)                   There are no Other Licenses that have been signed as of
the Effective Date; and
 
(p)                All Other Licenses entered into on or after the Effective
Date shall be in full compliance with the requirements for Other Licenses that
are set forth in this Agreement.
 
If either Party becomes aware of a breach or believed breach of this Section
11.2, it shall notify the other Party and the Parties shall discuss the matter
in good faith.  ANTHERA shall seek to cure any such breach to the fullest extent
possible.  If such a breach had occurred, and full cure was not possible, then
ANTHERA shall cure to the extent possible.
 
11.3           Remedies.  Either Party shall have the right to seek any remedy
under applicable law for any uncured breach of this Agreement, including, by way
of example only, any breach of Article 11, and subject to Section 11.5, the
breaching Party shall be responsible for any damages judicially determined or
finally-determined by an arbitrator in accordance with Article 15 to be payable
to the non-breaching Party as a result of such uncured breach. For clarity, this
Section 11.3 shall not be construed to limit the Parties’ rights under Article
13.
 
11.4           Disclaimer.  Except as expressly set forth herein, THE TECHNOLOGY
AND INTELLECTUAL PROPERTY RIGHTS PROVIDED BY EACH PARTY HEREUNDER ARE PROVIDED
“AS IS,” AND EACH PARTY EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND,
EXPRESS OR IMPLIED, INCLUDING THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS
FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS
OF THIRD PARTIES, OR ARISING FROM A COURSE OF DEALING, COURSE OF PERFORMANCE OR
TRADE PRACTICES.
 
11.5           Limitation of Liability.  Except in the case of breach of
Article 12, NEITHER PARTY SHALL BE ENTITLED TO RECOVER FROM THE OTHER PARTY ANY
SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES IN CONNECTION WITH THIS
AGREEMENT OR ANY LICENSE GRANTED HEREUNDER; provided, however, that this
Section 11.5 shall not be construed to limit either party’s indemnification
obligations under Article 14.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
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12.
Confidentiality

 
12.1           Confidential Information.  Except to the extent expressly
authorized by this Agreement or otherwise agreed in writing by the parties, each
party agrees that, during the Term and for seven years thereafter, such party
(the “Receiving Party”) shall keep confidential and shall not publish or
otherwise disclose and shall not use for any purpose, other than as expressly
provided for in this Agreement, any Information furnished to it by or on behalf
of the other party (the “Disclosing Party”) pursuant to this Agreement
(collectively, “Confidential Information”).  The Receiving Party may use such
Confidential Information only to the extent required to accomplish the purposes
of this Agreement. The Receiving Party shall use at least the same standard of
care as it uses to protect proprietary or confidential information of its own to
ensure that its and its Affiliates’ employees, agents, consultants and other
representatives do not disclose or make any unauthorized use of the Confidential
Information.  The Receiving Party shall promptly notify the Disclosing Party
upon discovery of any unauthorized use or disclosure of the Disclosing Party’s
Confidential Information.
 
12.2           Exceptions.  Confidential Information shall not include any
information which the Receiving Party can prove by competent evidence: (a) is
now, or hereafter becomes, through no act or failure to act on the part of the
Receiving Party, generally known or available; (b) is known by the Receiving
Party at the time of receiving such information, as evidenced by its records;
(c) is hereafter furnished to the Receiving Party by a Third Party, as a matter
of right and without restriction on disclosure; or (d) is independently
discovered or developed by the Receiving Party without the use of Confidential
Information of the Disclosing Party, as evidenced by the Receiving Party’s
written records maintained in the ordinary course of business.
 
12.3           Authorized Disclosure.  Each party may disclose Confidential
Information of the other party as expressly permitted by this Agreement, or if
and to the extent such disclosure is reasonably necessary in the following
instances:
 
(a)                   filing or prosecuting Patents as permitted by this
Agreement;
 
(b)                   enforcing such party’s rights under this Agreement;
 
(c)                   prosecuting or defending litigation as permitted by this
Agreement;
 
(d)                   complying with applicable court orders or governmental
regulations;
 
(e)                   in the case of ANTHERA, disclosure to Amgen in confidence
as necessary for compliance with the Amgen Agreement;
 
(f)                   disclosure to Affiliates, licensees and Sublicensees,
potential licensees and Sublicensees, contractors, employees and consultants who
need to know such information for the development, manufacture and
commercialization of Products in accordance with this Agreement, on the
condition that any such Third Parties agree to be bound by confidentiality and
non-use obligations that are no less stringent than the terms of this Agreement;
and
 
(g)                   disclosure to Third Parties in connection with due
diligence or similar investigations by such Third Parties, and disclosure to
potential Third Party investors in confidential financing documents, provided,
in each case, that any such Third Party agrees to be bound by reasonable
obligations of confidentiality and non-use.
 
Notwithstanding the foregoing, in the event a party is required to make a
disclosure of the other party’s Confidential Information pursuant to
Section 12.3(c) or Section 12.3(d), it shall give reasonable advance notice to
the other party of such disclosure and use efforts to secure confidential
treatment of such information at least as diligent as such party would use to
protect its own confidential information, but in no event less than reasonable
efforts.  In any event, the parties agree to take all reasonable action to avoid
disclosure of Confidential Information hereunder.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
37.

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12.4           Confidentiality of this Agreement.  Except as otherwise provided
in this Article 12, each party agrees not to disclose to any Third Party the
terms of this Agreement without the prior written consent of the other party
hereto, except that each party may disclose the terms of this Agreement that are
otherwise made public as contemplated by Section 12.5 or to the extent such
disclosure is permitted under Section 12.3.
 
12.5           Public Announcements.
 
(a)                    The Parties may issue individual press releases
announcing the execution of this Agreement, the timing and content of which
shall be mutually agreed, such agreement not to be unreasonably withheld. It is
further acknowledged that each party may desire or be required to issue
subsequent press releases relating to this Agreement or activities
hereunder.  The parties agree to consult with each other reasonably and in good
faith with respect to the text and timing of subsequent press releases prior to
the issuance thereof, provided that a party may not unreasonably withhold
consent to such releases, and that either party may issue such press releases as
it determines, based on advice of counsel, are reasonably necessary to comply
with applicable law (including disclosure requirements of the U.S. Securities
and Exchange Commission (“SEC”)) or with the requirements of any stock exchange
on which securities issued by a party or its Affiliates are traded.  In the
event of a required public announcement, the party making such announcement
shall provide the other party with a copy of the proposed text of such
announcement sufficiently in advance of the scheduled release to afford such
other party a reasonable opportunity to review and comment upon the proposed
text.  The amount of time in advance shall be reasonable under the
circumstances.  Each party may make accurate public statements regarding this
Agreement in response to questions by the press, analysts, investors or those
attending industry conferences or financial analyst calls, or issue press
releases, so long as any such public statement or press release is not
inconsistent with prior public disclosures or public statements approved by the
other party pursuant to this Section 12.5 or permitted by Section 12.3 and does
not reveal non-public information about the other party.
 
(b)                   The parties shall coordinate in advance with each other in
connection with the filing of this Agreement (including redaction of certain
provisions of this Agreement) with the SEC or other governmental agency or any
stock exchange on which securities issued by a party or its Affiliate are
traded, and each party shall use reasonable efforts to seek confidential
treatment for the terms proposed to be redacted.  A party required to file a
copy of this Agreement shall seek confidential treatment for those portions of
the Agreement requested by the other party, except to the extent advised by
outside counsel that confidential treatment is manifestly unavailable for any
text the other party requested by redacted.  The parties shall use their
reasonable efforts to file redacted versions with any governmental agencies
which are consistent with redacted versions previously filed with any other
governmental agencies.  Other than such obligation regarding redactions to a
publicly filed copy of this Agreement, neither party (or its Affiliates) shall
be obligated to consult with or obtain approval from the other party with
respect to any filings to the SEC or any stock exchange or other governmental
agency, as long as such filings do not disclose Confidential Information of the
other party.
 
(c)                   Notwithstanding anything express or implied, each party
shall obtain the other party’s advance written consent to each written
description of this Agreement by such party that does not merely repeat a
previously approved such written description (including the initial public
disclosure of this Agreement).  The non-disclosing party shall not unreasonably
withhold its consent to a reasonable description, in accordance with the
disclosing party’s legal disclosure obligations.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
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12.6           Publication.  Each party to this Agreement recognizes that the
publication of papers regarding results of research and development of Compound
and Product, including oral presentations and abstracts, may be beneficial to
both parties provided such publications are subject to reasonable controls to
protect Confidential Information and to preserve patentability of
inventions.  Accordingly, a party shall have the right to review and comment on
any material proposed for publication or public presentation by the other party,
such as by oral presentation, manuscript or abstract, which includes Data
generated from research and development of Compound and Product conducted by and
includes or was generated using or in reliance on Confidential Information of
the other party and which has not been previously disclosed non-confidentially.
Before any such material is submitted for publication, the party proposing
publication shall deliver a complete copy to the other party at least 45 days
prior to submitting the material to a publisher or initiating any other
disclosure.  Such other party shall review any such material and give its
comments to the party proposing publication within 30 days of the delivery of
such material to such other party.  With respect to oral presentation materials
and abstracts, such other party shall make reasonable efforts to expedite review
of such materials and abstracts, and shall return such items as soon as
practicable to the party proposing publication with appropriate comments, if
any, but in no event later than 30 days from the date of delivery to the
non-publishing party.  The publishing party shall comply with the other party’s
request to delete references to such other party’s Confidential Information in
any such material and agrees to delay any submission for publication or other
public disclosure for a period of up to an additional 90 days for the purpose of
preparing and filing appropriate patent applications.
 
12.7           Prior Non-Disclosure Agreements.  As of the Effective Date and
during the Term, the terms of this Article 12 shall supersede any prior
non-disclosure, secrecy or confidentiality agreement between the parties (or
their Affiliates) dealing with the subject of this Agreement. Any information
disclosed under such prior agreements shall be deemed disclosed under this
Agreement for purposes of this Article 12.
 
13.
Term and Termination

 
13.1           Term.  The term of this Agreement, unless earlier terminated
according to the Sections below, shall be from the Effective Date to the
expiration of the last-to-expire Valid Claim of the ANTHERA Patents or Joint
Patents Covering Product in any country in the ZENYAKU Territory.   For clarity,
ZENYAKU if it elects (by written notice no later than one (1) year prior to the
date that it anticipates such expiry will occur) shall have the right to
continue to obtain supply of Product from ANTHERA under the Product Supply
Agreement beyond such expiration, until the expiration of three (3) years after
either Party gives written notice to discontinue such supply; such termination
notice can only be given on or after expiry of this Agreement.  If ANTHERA is
unable to continue supply past the expiration of this Agreement, the Parties
shall reasonably cooperate to transition manufacturing over a reasonable period
of time to ZENYAKU or its chosen contract manufacturer(s); provided that they
shall use Commercially Reasonable Efforts to do so in a manner that does not
lead to a supply interruption (e.g., supply from ANTHERA to ZENYAKU shall not be
discontinued prior to the time that ZENYAKU or its contract manufacturer has
been validated and Compound and Product produced by them can be legally sold as
a pharmaceutical product in the ZENYAKU Territory).
 
13.2           Termination.
 
(a)                   Material Breach. A party shall have the right to terminate
this Agreement before the end of the Term upon written notice to the other party
if such other party is in material breach of this Agreement and has not cured
such breach within 120 days (or 60 days with respect to any payment breach)
after notice from the terminating party requesting cure of the breach.  Any such
termination shall become effective at the end of such 120-day (or 60-day with
respect to any payment breach) period unless the breaching party has cured such
breach prior to the end of such period.  Any right to terminate under this
Section 13.2(a) shall be stayed and the cure period tolled in the event that,
during any cure period, the party alleged to have been in material breach shall
have initiated dispute resolution with respect to the alleged breach, which stay
and tolling shall continue until such dispute has been resolved in accordance
with the dispute resolution process.  In addition, the parties may agree in
writing to stay and toll a termination in the case of ongoing discussions
between their dispute resolution officers under Article 15, if the parties
choose to extend the discussions of such officers beyond the time frame provided
for in such Article.  A party accused of material breach, or accused of not
curing a material breach, who in good faith disputes whether the breach
occurred, whether it was material, or whether it was cured, has the right to
invoke the dispute resolution provisions of Article 15 in relation to any of the
foregoing disagreements.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
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(b)                   Patent Challenge.  ANTHERA shall have the right to
terminate this Agreement before the end of the Term immediately upon written
notice to ZENYAKU if ZENYAKU or any of its Affiliates or Sublicensees, directly
or indirectly through any Third Party, commences any interference or opposition
proceeding with respect to, challenges the validity or enforceability of, or
opposes any extension of or the grant of a supplementary protection certificate
with respect to, any ANTHERA Patent.
 
(c)                   ZENYAKU Termination At Will.  ZENYAKU shall have the right
to terminate this Agreement, in whole or with respect to any country in the
ZENYAKU Territory for any reason or for no reason at any time, upon at least
120 days prior written notice to ANTHERA. In the event of ZENYAKU’s termination
of this Agreement pursuant to this Section 13.2(c) prior to completion of all
Joint Development Plan activities, ZENYAKU shall be responsible for applicable
per-patient fees that become due and Joint Development Plan costs that are
incurred in accordance with the Joint Development Plan during the applicable
notice period. Further, in the event this Agreement is terminated, prior to the
first dosing in the first Phase 3 Clinical Trial for a Product that is initiated
after the Effective Date of this Agreement, pursuant to Section 13.2(c), either
(x) in its entirety or (y) with respect to Japan, the Upfront Loan shall be
forgiven as of the effective date of such termination. ZENYAKU shall also have
the right to terminate this Agreement on 30 days prior written notice in the
event annual sales of Generic Product in the ZENYAKU Territory reach fifty
percent (50%) of annual sales of Product in the ZENYAKU Territory.
 
13.3           Effect of Expiration or Termination.
 
(a)                   Expiration.  Upon expiration (but not earlier termination)
of this Agreement, the License (including the Manufacturing License, which
ZENYAKU shall be entitled to practice) shall survive on a fully-paid and
royalty-free (in each case, subject to Section 7.5(b) and any Third Party
Payments), irrevocable, perpetual basis, and all other rights and obligations of
the parties under this Agreement shall terminate, except as provided elsewhere
in this Section 13.3(a) or in Section 13.4. For clarity, upon expiration (but
not earlier termination) of this Agreement, ZENYAKU shall be entitled to
practice the Manufacturing License and use any Third Party supplier for the
manufacture of Compounds and Products.
 
(b)                   Termination for ANTHERA’s Uncured Material Breach.  Upon
any termination of this Agreement by ZENYAKU pursuant to Section 13.2(a) for
ANTHERA’s uncured material breach, all rights and obligations of the parties
under this Agreement shall terminate (including, for clarity, ANTHERA’s
obligation to assume any development expenses for the Compound or Product, but
without altering ZENYAKU’s rights to recover its damages relating to such
material breach), including the right to terminate except that:
 
(i)          the licenses granted in Section 2.1 to ZENYAKU shall survive, as
shall all of ZENYAKU’s rights to data, disclosure, access, and reference set
forth in Sections 4.6, 4.7(b), 4.8, 4.12, and 4.13;
 
(ii)         the requirements for ANTHERA to use Commercially Reasonable Efforts
to obtain grant-back rights from Other Licensees as set forth in Article 2 shall
survive,
 
(iii)         all provisions providing for information exchange under Sections
4.6, 4.7, 4.8, 4.10, 4.12, and 4.13 to the extent that post-termination exchange
is necessary for either Party to comply with law shall survive;
 
(iv)         After the effective date of such termination, ANTHERA covenants
that it and its Affiliates and Other Licensees shall not conduct any clinical
trials of Compound or Product in the ZENYAKU Territory without ZENYAKU’s
advance, written, withholdable consent;
 
(v)         ZENYAKU shall pay Amgen the Amgen Royalty on ZENYAKU’s, its
Affiliates’, and their Sublicensees’ Net Sales, pursuant to and only for so long
as required by ZENYAKU’s Amgen Direct License.  In addition, ZENYAKU shall pay
any Third Party Payments ZENYAKU agreed in writing would be paid by ZENYAKU,
pursuant to and only for so long as required by the applicable Third Party
agreements;
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
40.

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(vi)         ZENYAKU’s payment obligations in Section 7.2 shall survive;
provided that, ZENYAKU shall be entitled to credit the amount of any damages
resulting from ANTHERA’s breaches of this Agreement (including milestone or
other payments to Amgen other than the Amgen Royalty) against any amounts
payable by ZENYAKU under this Agreement.  For clarity, ANTHERA will have the
right to challenge the amount of any such credit through the arbitration
procedures of Article 15.
 
(vii)         If ZENYAKU was not previously permitted to practice the
Manufacturing License, then ZENYAKU shall be permitted to exercise the
Manufacturing License from and after the effective date such termination of this
Agreement and the Cell Line Escrow and the Manufacturing Escrow shall be
released to ZENYAKU, at no cost to ZENYAKU.
 
(viii)         ZENYAKU shall have the right to continue to obtain supply of
Compound and Product from ANTHERA in accordance with this Section
13.3(b)(viii).  If ZENYAKU chooses to continue to obtain supply from ANTHERA
under the Product Supply Agreement following such effective date of termination
of this Agreement, then ANTHERA shall continue such supply for a period required
by ZENYAKU (which it is recognized may be an extended period, due to the time
required to complete manufacturing technology transfer to a contract
manufacturing and validate the new source of supply) on the terms and conditions
of the Product Supply Agreement; provided that ANTHERA may satisfy its
obligation to supply Compound and Product under this Section 13.3(b)(viii) by
assigning to ZENYAKU its supply and manufacturing agreements with its Third
Party manufacturers for the supply of Compound and Product, and providing full
technology transfer of the QA/QC procedures and protocols used by ANTHERA
previously in relation to supply to ZENYAKU, at no charge, and in such a manner
that ZENYAKYU shall not become responsible for amounts due under the assignments
agreement prior to the effective date of assignment (excluding any costs of
supply of Compound or Product ordered by ZENYAKU prior to the effective date of
assignment).  Upon such assignment of such Third Party contract manufacturing
agreements to ZENYAKU and completion of such QA/QC technology transfer,
ANTHERA’s obligation to supply Compound and Product pursuant to this Section
13.3(b)(viii) or the Product Supply Agreement shall terminate.
 
(ix)         As between the Parties, ZENYAKU shall have the first right  to
prosecute ANTHERA Patents in the ZENYAKU Territory and the first right as
between the Parties to enforce ANTHERA Patents, retaining all recoveries.
 
(x)         ZENYAKU will be entitled to assume all development, manufacture and
commercialization activities for Products in the ZENYAKU Territory, without any
input from or participation by ANTHERA and without any obligation to provide any
plans or budgets or other information other than safety reporting to
ANTHERA.  For clarity, ZENYAKU, its Affiliates and Sublicensees shall have no
right to conduct any research or development of Compound or Product in the
ANTHERA Territory without ANTHERA’s advance written consent, other than the
extra-territorial right to assay work provided for in Section 2.1.
 
(xi)         ANTHERA shall provide to ZENYAKU at no charge for a period of six
(6) months following the effective date of termination such transition
assistance as ZENYAKU may reasonably request.  This includes manufacturing
technology transfer assistance.
 
(xii)         Section 2.9(a) shall survive until there is no longer any
Patent  owned or Controlled by ANTHERA Covering Compound and/or Product in the
ZENYAKU Territory.
 
(c)                   Termination for ZENYAKU’s Uncured Material Breach or by
ZENYAKU’s At Will.  Upon any termination of this Agreement by ANTHERA pursuant
to Section 13.2(a) or (b) or by ZENYAKU pursuant to Section 13.2(c), all
licenses granted by ANTHERA to ZENYAKU, including the License and Manufacturing
License, shall automatically terminate and revert to ANTHERA, and all other
rights and obligations of the parties under this Agreement shall terminate,
except as provided elsewhere in this Section 13.3(c) or in Section 13.4. In
addition, the following provisions shall apply:
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
41.

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(i)         The licenses granted to ANTHERA pursuant to Section 2.7 shall
survive.
 
(ii)         Effective as of such termination, ZENYAKU shall, and it hereby
does, grant to ANTHERA an exclusive, with the right to sublicense through
multiple tiers of sublicense, under the ZENYAKU Technology, solely to develop,
make, have made, use, sell, offer for sale, and import Compound and Product in
the ZENYAKU Territory.
 
(iii)         Effective as of such termination, ZENYAKU shall, and it hereby
does, assign to ANTHERA all of ZENYAKU’s right, title and interest in and to the
ZENYAKU Product Marks, including all goodwill therein, and ZENYAKU shall
promptly take such actions and execute such instruments, assignments and
documents as may be necessary to effect, evidence, register and record such
assignment, at ANTHERA’s cost.
 
(iv)         As promptly as practicable ([***]) after such termination, ZENYAKU
shall: (A)  disclose to ANTHERA all previously-undisclosed ZENYAKU-generated
Data or Information relating to Compound or Product; (B) transfer or assign, or
cause to be transferred or assigned, to ANTHERA or its designee (or to the
extent not so assignable, take all reasonable actions to make available to
ANTHERA or its designee the benefits of) all regulatory filings and
registrations (including B.L.A.s and Regulatory Approvals) for Compound and
Product in the ZENYAKU Territory, whether held in the name of ZENYAKU, its
Affiliate or a Sublicensee; and (C) take such other actions and execute such
other instruments, assignments and documents as may be necessary to effect,
evidence, register and record the transfer, assignment or other conveyance of
rights under this Section 13.3(c)(iv) to ANTHERA.
 
(v)         ZENYAKU shall either wind-down any ongoing development activities
with respect to Compound and Product in the ZENYAKU Territory in an orderly
fashion or if requested by ANTHERA promptly transition such development
activities to ANTHERA or its designee, with due regard for patient safety and in
compliance with all applicable laws, rules and regulations and international
guidelines.
 
(vi)         ANTHERA shall have the right, but not the obligation, to purchase
from ZENYAKU any or all usable clinical and/or commercial inventory of Compound
and Product in ZENYAKU’s or it’s Affiliates’ possession as of the date of
termination.  Clinical inventory shall be provided at a transfer price equal to
ZENYAKU’s Cost of Goods, and commercial inventory shall be provided at a
transfer price equal to ZENYAKU’s Cost of Goods, increased by a five percent
(5%) markup (provided that, in each case, the definition of Cost of Goods shall
be read to refer to “ZENYAKU” instead of “ANTHERA”).  Any packaging, transport,
insurance and other costs relating to delivery shall be at ANTHERA’s expense.
 
(vii)         Any Sublicensees in good standing shall have the right to discuss
the terms and conditions on which they may obtain a direct license from ANTHERA
on the same terms on which such Sublicensees previously held sublicense rights
from ZENYAKU. ANTHERA shall for a period of [***], enter into discussions with
respect to such direct license with the requesting Sublicensee, provided,
however, that ANTHERA shall enter into such direct license at ANTHERA’s sole
discretion.
 
13.4             Accrued Obligations; Survival.  Neither expiration nor any
termination of this Agreement shall relieve either party of any obligation or
liability accruing prior to such expiration or termination, nor shall expiration
or any termination of this Agreement preclude either party from pursuing all
rights and remedies it may have under this Agreement, at law or in equity, with
respect to breach of this Agreement.  In addition, the parties’ rights and
obligations under Sections 2.10, 4.8 (to the extent required for legal
compliance by any party), 4.10, 4.13, 10.1, 11.3, 11.4, 11.5, 13.3, 13.4, and
13.5, and Articles 1, 8, 12, 14, 15, and 16 of this Agreement shall survive
expiration or any termination of this Agreement.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
42.

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13.5           Rights Upon Bankruptcy.  All rights and licenses granted under or
pursuant to this Agreement are, and shall otherwise be deemed to be, for
purposes of Section 365(n) of Title 11 of the United States Code and other
similar laws in any jurisdiction outside the U.S. (collectively, the “Bankruptcy
Laws”), licenses of rights to be “intellectual property” as defined under the
Bankruptcy Laws.  If a case is commenced during the Term by or against a party
under Bankruptcy Laws then, unless and until this Agreement is rejected as
provided in such Bankruptcy Laws, such party (in any capacity, including
debtor-in-possession) and its successors and assigns (including a trustee) shall
perform all of the obligations provided in this Agreement to be performed by
such party.  If a case is commenced during the Term by or against a party under
the Bankruptcy Laws, this Agreement is rejected as provided in the Bankruptcy
Laws and the other party elects to retain its rights hereunder as provided in
the Bankruptcy Laws, including its rights to receive any and all updates, then
the party subject to such case under the Bankruptcy Laws (in any capacity,
including debtor-in-possession) and its successors and assigns (including a
Title 11 trustee), shall provide to the other party copies of all Information
necessary for such other party to prosecute, maintain and enjoy its rights under
the terms of this Agreement promptly upon such other party’s written request
therefor, including any and all updates.  All rights, powers and remedies of the
non bankrupt party as provided herein are in addition to and not in substitution
for any and all other rights, powers and remedies now or hereafter existing at
law or in equity (including, without limitation, the Bankruptcy Laws) in the
event of the commencement of a case by or against a party under the Bankruptcy
Laws.
 
14.
Indemnification

 
14.1           Indemnification by ZENYAKU.  ZENYAKU hereby agrees to save,
defend, indemnify and hold harmless ANTHERA, its Affiliates and their respective
officers, directors, employees, consultants and agents (the “ANTHERA
Indemnitees”), from and against any and all losses, damages, liabilities,
expenses and costs, including reasonable legal expense and attorneys’ fees
(“Losses”), to which any ANTHERA Indemnitee may become subject as a result of
any claim, demand, action or other proceeding each of the foregoing by any Third
Party (“Claims”) to the extent such Claims (and the resulting Losses) arise
directly or indirectly out of: (a) the research, development, manufacture, use,
handling, storage, possession, transport, importation, distribution, promotion,
marketing, sale or other disposition of Compound or Product by or on behalf of
ZENYAKU or any of its Affiliates or Sublicensees; (b) the gross negligence or
willful misconduct of any ZENYAKU Indemnitee (defined below); or (c) the breach
by ZENYAKU of any warranty, representation, covenant or agreement made by it in
this Agreement; except, in each case, to the extent such Claims (and the
resulting Losses) result from the gross negligence or willful misconduct of any
ANTHERA Indemnitee or the breach by ANTHERA of any warranty, representation,
covenant or agreement made by it in this Agreement.
 
14.2           Indemnification by ANTHERA.  ANTHERA hereby agrees to save,
defend, indemnify and hold harmless ZENYAKU, its Affiliates and their respective
officers, directors, employees, consultants and agents (the “ZENYAKU
Indemnitees”), from and against any and all Losses to which any ZENYAKU
Indemnitee may become subject as a result of any Claims to the extent such
Claims (and the resulting Losses) arise directly or indirectly out of: (a) the
research, development, manufacture, use, handling, storage, possession,
transport, importation, distribution, promotion, marketing, sale or other
disposition of Compound or Product by or on behalf of ANTHERA or any of its
Affiliates or Other Licensees (to be clear, excluding any of the foregoing
activities conducted by ZENYAKU, its Affiliates and Sublicensees); (b) the gross
negligence or willful misconduct of any ANTHERA Indemnitee; or (c) the breach by
ANTHERA of any warranty, representation, covenant or agreement made by it in
this Agreement; except, in each case, to the extent such Losses result from the
gross negligence or willful misconduct of any ZENYAKU Indemnitee or the breach
by ZENYAKU of any warranty, representation, covenant or agreement made by it in
this Agreement.
 
14.3           Procedure.  In the event a party seeks indemnification under
Section 14.1 or 14.2, it shall inform the other party (the “Indemnifying Party”)
of a Claim as soon as reasonably practicable after such party (the “Indemnified
Party”) receives notice of the Claim (it being understood and agreed, however,
that the failure by an Indemnified Party to give notice of a Claim as provided
in this Section 14.3 shall not relieve the Indemnifying Party of its
indemnification obligation under this Agreement except and only to the extent
that such Indemnifying Party is actually damaged as a result of such failure to
give notice), shall permit the Indemnifying Party to assume direction and
control of the defense of the Claim (including the right to settle the Claim
solely for monetary consideration), and shall cooperate as requested (at the
expense of the Indemnifying Party on a purely pass-through basis) in the defense
of the Claim.  The Indemnified Party shall not agree to any settlement of such
Claim without the prior written consent of the Indemnifying Party.  The
Indemnifying Party shall not agree to any settlement of such Claim or consent to
any judgment in respect thereof that does not include a complete and
unconditional release of the Indemnified Party from all liability with respect
thereto, that imposes any liability or obligation on the Indemnified Party or
that acknowledges fault by the Indemnified Party; in each case, without the
prior written consent of the Indemnified Party.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
43.

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14.4           Insurance.  Each party, at its own expense, shall maintain
product liability and other appropriate insurance (or self-insure) in an amount
consistent with industry standards during the Term.
 
15.
Dispute Resolution

 
15.1           Dispute Resolution.  Except as expressly set forth in Article 3,
any dispute arising under or relating to the parties’ rights and obligations
under this Agreement shall be referred to the Chief Executive Officer of ANTHERA
and the Chief Executive Officer of ZENYAKU (or his or her designee) for
resolution.  In the event such individuals are unable to resolve such dispute
within 30 days of such dispute being referred to them, then, upon the written
request of either party to the other party, the dispute shall be subject to
arbitration in accordance with Section 15.2, except as set forth in Section 15.3
below.
 
15.2           Arbitration.
 
(a)                   Claims.  Subject to Section 15.3 below, any claim,
dispute, or controversy of whatever nature arising out of or relating to this
Agreement that is not resolved under Section 15.1 within the required 30-day
period, including, without limitation, any action or claim based on tort,
contract, or statute, or concerning the interpretation, effect, termination,
validity, performance and/or breach of this Agreement (“Claim”), shall be
resolved by final and binding arbitration administered by the International
Chamber of Commerce (“ICC”). The arbitration and all associated discovery
proceedings and communications shall be conducted in English, and the
arbitration shall be held in (1) San Francisco, California, USA if ZENYAKU
demanded the arbitration, or (2) Tokyo, Japan, if ANTHERA demanded the
arbitration.
 
(b)                   English Language.  All proceedings shall be held in
English and a transcribed record prepared in English.  Documents submitted in
the arbitration (the originals of which are not in English) shall be submitted
together with a reasonably complete and accurate English translation.
 
(c)                   Selection of Arbitrators.  The Parties shall each choose
one arbitrator within thirty (30) days of receipt of notice of the intent to
arbitrate and the said two arbitrators shall select by mutual agreement a third
arbitrator within thirty (30) days after they have been selected as
arbitrators.  If no arbitrator is appointed within the times herein provided or
any extension of time that is mutually agreed on, the ICC shall make such
appointment (i.e. shall appoint three arbitrators) within thirty (30) days of
such failure.  All arbitrators must be unaffiliated with both parties and
unaffiliated with both parties’ Affiliates.
 
(d)                   Arbitrators’ Award.  The arbitrator’s award shall include
a written statement describing the essential findings and conclusions on which
the award is based, including the calculation of any damages awarded.  The
arbitrator shall, in rendering his or her decision, apply the substantive laws
of the State of California, without giving effect to its conflicts of laws
principles.  The arbitrator’s authority to award special, incidental,
consequential or punitive damages shall be subject to the limitation set forth
in Section 11.5.  The award rendered by the arbitrator shall be final, binding
and non-appealable, and judgment may be entered upon it in any court of
competent jurisdiction.
 
(e)                   Costs.  Each party shall bear its own attorney’s fees,
costs, and disbursements arising out of the arbitration, and shall pay an equal
share of the fees and costs of the arbitrator; provided, however, the arbitrator
shall be authorized to determine whether a party is the prevailing party, and if
so, to award to that prevailing party reimbursement for any or all of its
reasonable attorneys’ fees, costs and disbursements (including, for example,
expert witness fees and expenses, photocopy charges, travel expenses, etc.),
and/or the fees and costs of the ICC and the arbitrator.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
44.

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15.3           Court Actions.  Nothing contained in this Agreement shall deny
either party the right to seek injunctive or other equitable relief from a court
of competent jurisdiction in the context of a bona fide emergency or prospective
irreparable harm, and such an action may be filed and maintained notwithstanding
any ongoing discussions between the parties or any ongoing arbitration
proceeding.  In addition, either party may bring an action in any court of
competent jurisdiction to resolve disputes pertaining to the validity,
construction, scope, enforceability, infringement or other violations of Patents
or other intellectual property rights, and no such claim shall be subject to
arbitration pursuant to Section 15.2.
 
16.
Miscellaneous

 
16.1           Governing Law.  This Agreement and any disputes, claims, or
actions related thereto shall be governed by and construed in accordance with
the laws of the State of California, USA, without regard to the conflicts of law
provisions thereof.
 
16.2           Entire Agreement; Amendment.  This Agreement, including the
Exhibits hereto, is both a final expression of the parties’ agreement and a
complete and exclusive statement with respect to all of its terms. This
Agreement supersedes all prior and contemporaneous agreements and
communications, whether oral, written or otherwise, concerning any and all
matters contained herein.  This Agreement may only be modified or supplemented
in a writing expressly stated for such purpose and signed by the parties to this
Agreement.
 
16.3           Relationship Between the Parties.  The parties’ relationship, as
established by this Agreement, is solely that of independent contractors.  This
Agreement does not create any partnership, joint venture, agency, or similar
business relationship between the parties.  Neither party is a legal
representative of the other party, and neither party can assume or create any
obligation, representation, warranty or guarantee, express or implied, on behalf
of the other party for any purpose whatsoever.
 
16.4           Non-Waiver.  The failure of a party to insist upon strict
performance of any provision of this Agreement or to exercise any right arising
out of this Agreement shall neither impair that provision or right nor
constitute a waiver of that provision or right, in whole or in part, in that
instance or in any other instance.  Any waiver by a party of a particular
provision or right shall be in writing, shall be as to a particular matter and,
if applicable, for a particular period of time and shall be signed by such
party.
 
16.5           Assignment.
 
(a)                   Except as expressly provided hereunder, neither this
Agreement nor any rights or obligations hereunder may be assigned or otherwise
transferred by either party without the prior written consent of the other party
(which consent shall not be unreasonably withheld); provided, however, that
either party may assign this Agreement and its rights and obligations hereunder
without the other party’s consent: (a) in connection with the transfer or sale
of all or substantially all of the business of such party to which this
Agreement relates to a Third Party, whether by merger, sale of stock, sale of
assets or otherwise, provided that in the event of a transaction (whether this
Agreement is actually assigned or is assumed by the acquiring party by operation
of law (e.g., in the context of a reverse triangular merger)); or (b) to an
Affiliate for so long as such Affiliate remains an Affiliate, provided that the
assigning party shall remain liable and responsible to the non-assigning party
hereto for the performance and observance of all such duties and obligations by
such Affiliate.  The rights and obligations of the parties under this Agreement
shall be binding upon and inure to the benefit of the successors and permitted
assigns of the parties, and the name of a party appearing herein shall be deemed
to include the name of such party’s successors and permitted assigns to the
extent necessary to carry out the intent of this section.  Any assignment not in
accordance with this Agreement shall be void.
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
45.

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(b)                   Notwithstanding anything to the contrary herein, in the
event of an Industry Transaction of ANTHERA, for purposes of this Agreement,
(1) only those assets of ANTHERA and its Affiliates in existence before the
Industry Transaction will be subject to Section 2.9(a), and (2) ANTHERA shall
not be deemed to Control (i) any material, products, compounds, Information,
Patent, regulatory materials or regulatory approvals of the applicable Drug
Company (or any of its Affiliates that become Affiliates of ANTHERA as a result
of such Industry Transaction) that existed prior to such Industry Transaction,
or (ii) any material, products, compounds, Information, Patent, regulatory
materials or regulatory approvals of such Drug Company (or any of its Affiliates
that are not ANTHERA or any subsidiaries of ANTHERA) that are first Controlled
after the date of such Industry Transaction, in the case of (i) and (ii) both
(A) for so long as ANTHERA (or, in the case of an acquisition of ANTHERA’s
assets by such Drug Company, the applicable program of such Drug Company)
continues to conduct any development activities under this Agreement completely
independently of such Drug Company or any such Affiliates (or, in the case of an
acquisition of ANTHERA’s assets by such Drug Company, any other programs of such
Drug Company and its Affiliates) and the Information and Patents or the
foregoing, and (B) without any material license, disclosure, sharing or other
transfer of ANTHERA Technology, ZENYAKU Technology or use by, such Drug Company
or any such Affiliates, in each case for this clause (B) to develop or
commercialize any Compound, Product, or Competing Product.
 
(c)                   Notwithstanding anything to the contrary herein, in the
event of an Industry Transaction of ZENYAKU, for purposes of this Agreement, (1)
only those assets of ZENYAKU and its Affiliates in existence before the Industry
Transaction will be subject to Section 2.9(b), and (2) ZENYAKU shall be not
deemed to Control (i) any material, products, compounds, Information, Patent,
regulatory materials or regulatory approvals of the applicable Drug Company (or
any of its Affiliates that become Affiliates of ZENYAKU as a result of such
Industry Transaction) that existed prior to such Industry Transaction, or (ii)
any material, products, compounds, Information, Patent, regulatory materials or
regulatory approvals of such Drug Company (or any of its Affiliates that are not
ZENYAKU or any subsidiaries of ZENYAKU) that are first Controlled after the date
of such Industry Transaction, in the case of (i) and (ii) both (A) for so long
as ZENYAKU (or, in the case of an acquisition of ZENYAKU’s assets by such Drug
Company, the applicable program of such Drug Company) continues to conduct any
development activities under this Agreement completely independently of such
Drug Company or any such Affiliates (or, in the case of an acquisition of
ZENYAKU’s assets by such Drug Company, any other programs of such Drug Company
and its Affiliates) and the Information and Patents of the foregoing, and
(B) without any material license, disclosure, sharing or other transfer of
ANTHERA Technology or ZENYAKU Technology to, or use by, such Drug Company or any
such Affiliates, in each case for this clause (B) to develop or commercialize
any Compound, Product, or Competing Product.
 
16.6           No Third Party Beneficiaries.  This Agreement is neither
expressly nor impliedly made for the benefit of any party other than those
executing it.
 
16.7           Severability.  If, for any reason, any part of this Agreement is
adjudicated invalid, unenforceable or illegal by a court of competent
jurisdiction, such adjudication shall not affect or impair, in whole or in part,
the validity, enforceability or legality of any remaining portions of this
Agreement.  All remaining portions shall remain in full force and effect as if
the original Agreement had been executed without the invalidated, unenforceable
or illegal part.
 
16.8           Notices.  Any notice to be given under this Agreement must be in
writing and delivered either in person, by any method of mail (postage prepaid)
requiring return receipt, or by overnight courier or facsimile confirmed
thereafter by any of the foregoing, to the party to be notified at its
address(es) given below, or at any address such party has previously designated
by prior written notice to the other.  Notice shall be deemed sufficiently given
for all purposes upon the earliest of:  (a) the date of actual receipt; (b) if
mailed, five days after the date of postmark; or (c) if delivered by express
courier, the next business day the courier regularly makes deliveries in the
country of the recipient.
 
If to ANTHERA:
[ *** [
With a copy to:
[***]
 
[***]
If to ZENYAKU:
[***]
With a copy to:
 
[***]
 
[***]

 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
46.

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16.9           Force Majeure.  Each party shall be excused from liability for
the failure or delay in performance of any obligation under this Agreement by
reason of any unforeseen, extraordinary event beyond such party’s reasonable
control including but not limited to Acts of God, fire, flood, explosion,
earthquake, or other natural forces, war, civil unrest, acts of terrorism,
accident, destruction or other casualty, any lack or failure of transportation
facilities, any lack or failure of supply of raw materials, any strike or labor
disturbance, or any other event similar to those enumerated above.  Such excuse
from liability shall be effective only to the extent and duration of the
event(s) causing the failure or delay in performance and provided that the party
has not caused such event(s) to occur.  Notice of a party’s failure or delay in
performance due to force majeure must be given to the other party within 30 days
after its occurrence. All delivery dates under this Agreement that have been
affected by force majeure shall be tolled for the duration of such force
majeure.  In no event shall any party be required to prevent or settle any labor
disturbance or dispute.  A party’s failure to finance shall not be considered a
force majeure event providing an excuse under this Section 16.9.
 
16.10           Interpretation.  The headings of clauses contained in this
Agreement preceding the text of the sections, subsections and paragraphs hereof
are inserted solely for convenience and ease of reference only and shall not
constitute any part of this Agreement, or have any effect on its interpretation
or construction.  All references in this Agreement to the singular shall include
the plural where applicable.  Unless otherwise specified, references in this
Agreement to any Article shall include all Sections, subsections and paragraphs
in such Article, references to any Section shall include all subsections and
paragraphs in such Section, and references in this Agreement to any subsection
shall include all paragraphs in such subsection.  All references to days in this
Agreement shall mean calendar days, unless otherwise specified.  Ambiguities and
uncertainties in this Agreement, if any, shall not be interpreted against either
party, irrespective of which party may be deemed to have caused the ambiguity or
uncertainty to exist.  This Agreement has been prepared in the English language
and the English language shall control its interpretation.  In addition, all
notices required or permitted to be given hereunder, and all written,
electronic, oral or other communications between the parties regarding this
Agreement shall be in the English language.
 
16.11           Counterparts.  This Agreement may be executed in counterparts,
including by transmission of facsimile or PDF copies of signature pages to the
parties or their representative legal counsel, each of which shall be deemed an
original document, and all of which, together with this writing, shall be deemed
one instrument.
 
[Remainder of this page intentionally left blank.]
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
47.

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In Witness Whereof, the parties hereto have duly executed this Collaboration and
License Agreement as of the Effective Date.
 
 
ANTHERA Pharmaceuticals, Inc.
  ZENYAKU           By:  /s/  Paul F. Truex   By:
/s/ Koichi Hashimoto
          Print Name:
Paul F. Truex
  Print Name:
Koichi Hashimoto
          Title:
President and Chief Executive Officer 
  Title:
President and Chief Executive Officer

 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
 

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Exhibit A
 
Amgen Agreement
 
The agreements originally attached hereto as Exhibit A have been filed
separately with the Securities and Exchange Commission as follows:
 
 
1.
License Agreement between Amgen Inc. and the Company, dated as of December 18,
2007 (filed as Exhibit 10.10 to the registrant’s Registration Statement on Form
S-1 (File No. 333-161930), filed with the SEC on September 15, 2009).

 
2.
Amendment No. 1 to License Agreement between Amgen Inc. and the Company, dated
as of October 16, 2009 (filed as Exhibit 10.18 to the registrant’s Amendment No.
1 to Registration Statement on Form S-1 (File No. 333-161930), filed with the
SEC on October 19, 2009).

 
3.
Amendment No. 2 to License Agreement between Amgen Inc. and the Company, dated
as of November 26, 2014 (filed as Exhibit 10.23 to this Annual report on Form
10-K for the year ended December 31, 2014).

 
 
 
 

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Exhibit B
 
ANTHERA Patents
 
 
[***]
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
 

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Exhibit C
 
Initial Joint Development Plan
 
 
[***]
 
*** Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
 

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The following document has not been executed as of the filing date of this
report
 
Exhibit D
 
Loan Documentation
 
 
 

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Exhibit E
 
Stock Purchase Agreement
 
The agreement originally attached hereto as Exhibit E have been filed separately
with the Securities and Exchange Commission as follows:
 
 
1.
Stock Purchase Agreement between the Company and Zenyaku Kogyo Co., Ltd., dated
as of December 11, 2014 (filed as Exhibit 10.34 to this Annual report on Form
10-K for the year ended December 31, 2014).

 
 
 

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Exhibit F
 
Blisibimod Composition
 
:
 
[***]
 
* Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
 
Exhibit G

[***]
 
* Confidential Information, indicated by [***], has been omitted from this
filing and filed separately with the Securities and Exchange Commission.
 
 
 

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