Exhibit 10.1


 


Execution Version


 


COLLABORATION AND EXCLUSIVE
LICENSE AGREEMENT


 


This COLLABORATION AND
EXCLUSIVE LICENSE AGREEMENT (the “Agreement”)
is entered into as of the 25th day of May, 2008 (the “Effective Date”) by and between AMAG
PHARMACEUTICALS, INC., a Delaware corporation with its principal
place of business at 125 CambridgePark Drive, Cambridge, MA 02140, U.S.A. (“AMAG”), and 3SBIO
INC., a company incorporated under the laws of the Cayman Islands, with a
place of business at No. 3 A1 Road 10, Shenyang Economy &
Technology Development Zone, Shenyang, 110027, China (“3SBio”). 
AMAG and 3SBio are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”


 


RECITALS


 


WHEREAS, AMAG is developing its proprietary drug candidate
known as ferumoxytol as an intravenous iron replacement therapy, and has
submitted a New Drug Application to the U.S. Food and Drug Administration for
ferumoxytol as an intravenous treatment of iron deficiency anemia in patients
with chronic kidney disease;


 


WHEREAS, 3SBio possesses substantial resources and expertise
in the development, marketing, and commercialization of pharmaceutical products
in China;


 


WHEREAS, 3SBio desires to obtain exclusive rights to assist
in the further development and commercialization of ferumoxytol in China, and
AMAG is willing to grant such rights on the terms and conditions hereof.


 


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


 


ARTICLE 1

DEFINITIONS


 


As used in this Agreement, the following initially
capitalized terms, whether used in the singular or plural form, shall have the
meanings set forth in this Article 1.


 


1.1                               “3SBio Marks” has the meaning set forth in Section 5.7(b).


 


1.2                               “3SBio Proposed
Indication” has
the meaning set forth in Section 3.3.


 


1.3                               “Additional Indication” has the meaning set forth in Section 3.3.


 


1.4                               “Affiliate” means, with respect to a particular
Party, a person, corporation, partnership, or other entity that controls, is
controlled by or is under common control with such Party.  For the purposes of this definition, the word
“control” (including, with correlative meaning, the terms “controlled by” or “under
the common control with”) means the actual power, either directly or indirectly
through one or more intermediaries, to direct or cause the direction of the
management and policies of such entity, whether by the ownership of fifty
percent (50%) or more of the voting stock of such entity, or by contract or
otherwise.


 


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1.5                               “AMAG House Marks” means the AMAG names and logo as set
forth in Exhibit B.


 


1.6                               “AMAG Know-How” means all Information that is Controlled by
AMAG during the Term and is necessary for the Development or Commercialization
of the Product in the Licensed Territory.


 


1.7                               “AMAG Materials” has the meaning
set forth in 5.8(a).


 


1.8                               “AMAG Product Marks” means all trademarks in the Licensed
Territory related to the Product that are Controlled by AMAG during the
Term.  The AMAG Product Marks in
existence (or for which AMAG has submitted an application) as of the Effective
Date are set forth in Exhibit B.


 


1.9                               “AMAG Territory” means worldwide except the Licensed
Territory.


 


1.10                        “Budget” has the meaning
set forth in Section 2.2(a)(iii).


 


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


 


1.12                        “CMC” means chemistry, manufacturing and
controls as specified by the FDA.


 


1.13                        “Co-Developed Indication” has the meaning set forth in Section 3.3.


 


1.14                        “Co-Developed Indication Clinical
Studies” has the
meaning set forth in Section 3.4(b).


 


1.15                        “Co-Developed Indication Phase
III Clinical Trials”  has the meaning set forth in Section 3.4(b).


 


1.16                        “Collaboration Patents” has the meaning
set forth in Section 9.3.


 


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


 


1.18                        “Confidential Information” means, with respect to a Party, all
Information of such Party that is disclosed to the other Party under this
Agreement, which may include specifications, know-how, trade secrets, technical
information, drawings, models, business information, inventions, discoveries,
methods, procedures, formulae, protocols, techniques, data, and unpublished
patent applications, whether disclosed in oral, written, graphic, or electronic
form.  All Information disclosed by
either Party pursuant to the Confidentiality Agreement between the Parties,
dated October 15, 2007, shall be deemed to be such Party’s Confidential
Information disclosed hereunder.


 


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1.19                        “Control” means, with
respect to any Information or intellectual property right, the possession
(whether by ownership or license, other than pursuant to this Agreement) by a
Party of the ability to grant to the other Party access or license as provided
herein under such Information or right without violating the terms of any
agreement or other arrangement with any Third Party.


 


1.20                        “Detail” or “Detailing” means, with respect to the Product, the
communication by a Sales Representative during a Sales Call (a) involving
face-to-face contact, (b) describing in a fair and balanced manner the
SFDA-approved indicated uses and other relevant characteristics of the Product,
(c) using the Promotional Materials in an effort to increase the
prescribing and/or hospital ordering preferences of the Product for its
SFDA-approved indicated uses, and (d) made at such medical professional’s
office, in a hospital, at marketing meetings sponsored by 3SBio for the Product
or other appropriate venues conducive to pharmaceutical product informational
communication where the principal objective is to place an emphasis, either
primary or secondary, on the Product and not simply to discuss the Product with
such medical professional.  For the
avoidance of doubt, discussions at conventions or other meetings not
specifically sponsored by 3SBio for the Product shall not constitute “Details”
or “Detailing”.


 


1.21                        “Develop” or “Development” means all activities relating to
preparing and conducting preclinical testing, toxicology testing, human
clinical studies, regulatory affairs, manufacturing process development and
associated validation, quality assurance and quality control prior to the First
Commercial Sale of the Product for a specific indication in the Licensed
Territory.


 


1.22                        “Development Plans” has the meaning set forth in Section 3.4.


 


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


 


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


 


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


 


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


 


1.27                        “Field” means the treatment of any disease or
condition in humans, and expressly excludes diagnostic, imaging and all other
non-therapeutic applications.


 


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1.28                        “First Commercial Sale” means the first
sale to a Third Party of the Product in a given regulatory jurisdiction after
Regulatory Approval has been obtained in such jurisdiction.


 


1.29                        “Generic Entry Trigger” has the meaning set forth in Section 8.4(c).


 


1.30                        “Generic
Version” means, with respect to the Product, any Third Party
product that [***].


 


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


 


1.32                        “ICC Rules” has the meaning
set forth in Section 14.3.


 


1.33                        “Independent Indication” has the
meaning set forth in Section 3.3.


 


1.34                        “Information” means any data, results, technology or
information of any type whatsoever, in any tangible or intangible form,
including, without limitation, know-how, trade secrets, practices, techniques,
methods, processes, inventions, developments, specifications, formulations,
formulae, materials or compositions of matter of any type or kind (patentable
or otherwise), software, algorithms, marketing reports, expertise, technology,
test data (including pharmacological, biological, chemical, biochemical,
toxicological, preclinical and clinical test data), analytical and quality
control data, CMC information, stability data, other study data and procedures.


 


1.35                        “Initial Indication” means the treatment of iron deficiency
anemia in patients with chronic kidney disease.


 


1.36                        “Initial Indication Development
Plan” means the
plan for conducting Development of the Product for the Initial Indication for
use in the Licensed Territory, as described in Section 3.2.


 


1.37                        “Initial Indication Studies” has the meaning set forth in Section 3.4(a).


 


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


 


1.39                        “Joint Steering Committee” or “JSC” means the
committee formed by the Parties as described in Section 2.2(a).


 


1.40                        “Laws” means all laws, statutes, rules,
regulations, ordinances and other pronouncements having the effect of law of
any Governmental Authority.


 






[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN
FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 


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1.41                        “Licensed Territory” means the People’s Republic of China
(excluding Hong Kong SAR, Macau SAR and Taiwan region).


 


1.42                        “Manufacture”, with a correlative meaning for “Manufacturing,” means all activities related to the
manufacturing of a pharmaceutical product, or any ingredient thereof, including
manufacturing the product in finished form for Development, manufacturing
finished product for Commercialization, packaging,  in-process
and finished product testing, release of product or any component or ingredient
thereof, quality assurance activities related to manufacturing and release of
product, ongoing stability tests, and regulatory activities related to any of
the foregoing.


 


1.43                        “Marketing Authorization
Application” or “MAA” means an application submitted to a Regulatory
Authority seeking approval for the sale of a pharmaceutical product in the Licensed
Territory.


 


1.44                        “Marketing Plan” means each plan for Commercializing the
Product for the Initial Indication and each Co-Developed Indication in the
Licensed Territory, developed by 3SBio, as described in Section 5.1.


 


1.45                        “Net Sales” means, with respect to a particular time
period, the total amounts billed by 3SBio, its Affiliates and their respective
permitted sublicensees for sales of Products made during such time period to
unaffiliated Third Parties, less the following deductions to the extent
actually allowed or incurred with respect to such sales:


 


(a)                                  discounts, including cash and quantity
discounts, charge-back payments, and rebates actually granted to trade
customers, managed health care organizations, federal, state, or local
government and the agencies, purchasers and reimbursers of managed health
organizations or federal, state or local government;


 


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


 


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


 


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


 


Notwithstanding the
foregoing, amounts billed by 3SBio, its Affiliates, or their respective permitted
sublicensees for the sale of Products among 3SBio, its Affiliates or their
respective permitted sublicensees for resale shall not be included in the
computation of Net Sales hereunder.  Net
Sales shall be accounted for in accordance with U.S. generally accepted
accounting principles, consistently applied.  
Any price discounts offered by 3SBio, its Affiliates, or their
respective permitted sublicensees to purchasers of a Product will not exceed
the discount levels that are reasonable for products that are comparable to
such Product at a similar stage in the product life cycle.  3SBio shall apply all terms and conditions
applicable to the sale of Products (including any discounts applicable to
Products) in a reasonable and non-discriminatory


 


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manner relative to other products sold by 3SBio
together with Products.  3SBio shall not
bundle or combine the Product for sale together with another pharmaceutical
product without the prior written consent of AMAG.


 


1.46                        “New Product Marks” has the meaning set forth in Section 5.7(a).


 


1.47                        “Out-of-Pocket Costs” means any amounts paid by a Party to
Third Parties in connection with activities or services conducted by such Third
Parties, including but not limited to contract research, laboratory services,
consulting services, shipping and distribution, and costs of comparator
materials used in any clinical trial.


 


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


 


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


 


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


 


1.51                        “Phase IV Clinical Trial” means a clinical trial of the Product
conducted after Regulatory Approval of the Product has been obtained from an
appropriate Regulatory Authority, which trial is (a) conducted voluntarily
by a Party to enhance marketing or scientific knowledge of the Product (e.g., for expansion of Product Labeling or dose
optimization), or (b) conducted due to a request or requirement of a
Regulatory Authority.  For clarity, a
human clinical trial conducted to support a new Regulatory Approval of a Product
(e.g., for an Additional Indication)
shall not be considered a Phase IV Clinical Trial.


 


1.52                        “Pricing Approval” means such approval, agreement,
determination or governmental decision establishing prices for the Product that
can be charged to consumers and will be reimbursed by Governmental Authorities
in countries, territories or possessions where Governmental Authorities or
Regulatory Authorities of such country, territory or possession approve or
determine pricing of pharmaceutical products for reimbursement or otherwise.


 


1.53                        “Primary Position Detail”
means a Detail during which (a) the Product is discussed either itself or
along with other pharmaceutical products, (b) key product attributes of
the Product are verbally promoted in the first position on such Detail, and (c) the
Product is given the majority of the emphasis during the presentation.  For clarity, no more than one Detail during a
Sales Call shall be considered a Primary Position Detail.


 


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1.54                        “Product” means AMAG’s
proprietary iron replacement therapeutic product known as ferumoxytol, as
described on Exhibit A, and
that (a) is
formulated for intravenous delivery and has a dosage of 510 mg/vial, or (b) has
any other dosage form, strength or route of administration included in an MAA
filed with the FDA for the Initial Indication or a Co-Developed Indication.


 


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


 


1.56                        “Product Infringement” has the meaning set forth in Section 9.4(b)(i).


 


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


 


1.58                        “Project Manager” has the meaning set forth in Section 2.3.


 


1.59                        “Promotional Materials” means all sales representative training
materials and all written, printed, graphic, electronic, audio or video
presentations of information, including, without limitation, journal
advertisements, sales visual aids, formulary binders, reprints, direct mail,
direct-to-consumer advertising, internet postings, broadcast advertisements and
sales reminder aides (for example, note pads, pens and other such items)
intended for use or used by 3SBio or its Affiliates, permitted sublicensees or
licensees in connection with any promotion of the Product in the Licensed
Territory, but excluding Product Labeling.


 


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


 


1.61                        “Regulatory Authority” means, in a
particular country or jurisdiction, any applicable Governmental Authority
involved in granting Regulatory Approval in such country or jurisdiction,
including without limitation the FDA and SFDA.


 


1.62                        “Regulatory Fees” means all filing and administrative fees
required to be made to a Regulatory Authority in connection with obtaining
Regulatory Approval for the Product for the Initial Indication or for a
Co-Developed Indication, as applicable, in the Licensed Territory.


 


1.63                        “Regulatory Materials” means regulatory applications,
submissions, notifications, registrations, Regulatory Approvals and/or other
filings made to or with a Regulatory Authority that are necessary or reasonably
desirable in order to Develop, Manufacture, market, sell or otherwise
Commercialize the Product in a particular country, territory or
possession.  Regulatory Materials
include, without limitation, MAAs and applications for Pricing Approvals.


 


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1.64                        “Sales Call”
means a personal visit by a Sales Representative to one or several medical
professional(s) having prescribing authority in the Initial Indication or
Additional Indications for which such Product has received Regulatory Approval,
as well as to other individuals or entities that have significant impact or
influence on prescribing decisions in such indications, during which such Sales
Representative Details the Product.


 


1.65                        “Sales Representative”
means a pharmaceutical sales representative engaged or employed by 3SBio or its
Affiliate to conduct Detailing and other promotional efforts with respect to
the Product and who has been trained by AMAG or 3SBio in accordance with the
terms of this Agreement.


 


1.66                        “SFDA” means the State Food and Drug
Administration, or any successor thereto, that coordinates the scientific
review of human pharmaceutical products in China.


 


1.67                        “Shared Costs” has the meaning set forth in Section 3.7.


 


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


 


1.69                        “Third Party” means any entity other than AMAG or 3SBio
or an Affiliate of either of them.


 


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


 


ARTICLE 2

MANAGEMENT


 


2.1                               Collaboration Guidelines. 
In all matters relating to this Agreement, each Party shall seek to
comply with good pharmaceutical and business practices consistent with its own
existing practices.  Subject to the terms
of this Agreement, the activities and resources of each Party shall be managed
by such Party, acting independently and in its individual capacity.


 


2.2                               Joint Steering Committee.


 


(a)                                  Formation and Role. 
The Parties desire to establish a Joint Steering Committee (the “JSC”) that will monitor and coordinate communication
regarding the Parties’ efforts under this Agreement to Develop, obtain
Regulatory Approval for, and Commercialize the Product in the Field in the
Licensed Territory.  The JSC shall have
the membership and authority, and shall operate by the procedures, set forth
for it in this Section 2.2.  The
role of the JSC shall be:


 


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


 


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(ii)                                to review and approve each Development
Plan and any amendments thereto;


 


(iii)                            to review and approve in advance the
overall budget (each, a “Budget”)
associated with each Development Plan, and any amendment to a Budget that
increases by twenty-five percent (25%) or more the total expenditures under
such previously-approved Budget;


 


(iv)                               to approve any clinical studies
(including related protocols) to be conducted by the Parties for the Initial
Indication and each Co-Developed Indication;


 


(v)                                   for the Initial Indication and each
Co-Developed Indication, to review and approve all Regulatory Materials and
Product Labeling for the Product in the Licensed Territory;


 


(vi)                               to review and approve each Marketing
Plan, promotional strategy, and Promotional Materials for the Product, and any
updates and amendments thereto;


 


(vii)                           to establish such additional joint
subcommittees or committees as the JSC deems necessary to achieve the
objectives and intent of this Agreement; and


 


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


 


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


 


(b)                                  Membership.  Each Party shall have an equal number of
representatives on the JSC.  AMAG and
3SBio shall each initially designate three (3) representatives to serve on
the JSC, who shall be the individuals set forth in Exhibit C.  Either Party may designate substitutes for
its representatives if one (1) or more of such Party’s designated
representatives is unable to be present at a meeting.  To the extent possible, each Party shall
maintain the same representatives to the JSC during the Term; provided, each Party may replace its representatives as
necessary by written notice to the other Party specifying the prior
representative(s) and their replacement(s).  Any such substitutes or replacements shall be
designated consistent with the following principles: at least one (1) representative
of each Party shall have appropriate expertise in the Development of
pharmaceutical products, and at least one (1) representative of each Party
shall have appropriate expertise in the Commercialization of pharmaceutical
products.  AMAG shall select one (1) of
its representatives as the initial chairperson of the JSC.  On each anniversary of the Effective Date,
the Parties shall rotate designation of the JSC chairperson for each commencing
year.  The chairperson of the JSC shall
be responsible for (i) calling meetings, and (ii) preparing and
circulating an agenda for the upcoming meeting of the JSC, but shall have no special
authority over the other members of the JSC, and shall have no additional
voting


 


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rights.  The chairperson, or his or her designee,
shall be responsible for preparing and issuing minutes of each such meeting
within thirty (30) days thereafter.  Such
minutes will not be finalized until the other Party reviews and confirms the
accuracy of such minutes in writing.


 


(c)                                  Meetings.  The JSC shall hold at least four (4) meetings
per year within thirty (30) days of the end of each calendar quarter.  Meetings shall be effective only if at least
two (2) representatives of each Party are present or participating.  The JSC may meet either (i) in person at
either Party’s facilities or at such locations as the Parties may otherwise
agree, or (ii) by audio or video teleconference, provided that at least
one (1) meeting per year shall be in person.  With the prior consent of each Party’s
representatives, other representatives of each Party or Third Parties involved
with the Product may attend meetings as nonvoting participants.  Additional meetings of the JSC may also be
held with the consent of each Party, or as required under this Agreement, and
neither Party will unreasonably withhold or delay its consent to hold such an
additional meeting.  Each Party shall be
responsible for all of its own expenses incurred in connection with
participating in the JSC.


 


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


 


(e)                                  Decision-Making. 
Actions to be taken by the JSC shall be taken only following unanimous
vote, with each Party having one (1) vote. 
If the JSC fails to reach unanimous agreement on a matter before it for
decision for a period in excess of ten (10) days, the matter shall be
referred to the Chief Executive Officers of the Parties pursuant to Section 14.2.


 


(f)                                    Withdrawal. 
At any time during the Term and for any reason, AMAG shall have the
right to withdraw from participation in the JSC upon written notice to 3SBio,
which notice shall be effective immediately upon receipt (“Withdrawal
Notice”).  Following the
issuance of a Withdrawal Notice and subject to this Section 2.2(f), AMAG’s
representatives to the JSC shall not participate in any meetings, nor shall
AMAG have any right to vote on decisions within the authority of the JSC.  If, at any time following the issuance of a
Withdrawal Notice, AMAG wishes to resume participating in the JSC, AMAG shall
notify 3SBio in writing and, thereafter, AMAG representatives to the JSC shall be
entitled to attend any subsequent meeting and to participate in the activities
of, and decision-making by, the JSC as provided in this Article 2 as if a
Withdrawal Notice had not been issued by AMAG. 
Following AMAG’s issuance of a Withdrawal Notice pursuant to this Section 2.2(f),
unless and until AMAG resumes participation in the JSC in accordance with this
Section:  (i) all meetings of the
JSC shall be held at 3SBio’s facilities; (ii) 3SBio shall have the right
to make the final decision on all matters within the scope of authority of the
JSC; and (iii) AMAG shall have the right to continue to


 


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receive all reports and
materials provided to the JSC hereunder as well as reasonable advance notice of
any pending JSC decisions relating to the matters described in Section 14.2,
but shall not have the right to approve the minutes for any JSC meeting held
after issuance of such Withdrawal Notice. 
For clarity, the withdrawal by AMAG under this Section 2.2(f) shall
only limit AMAG’s obligations under this Article 2 with respect to
participation in the JSC.


 


2.3                               Project Managers. 
Promptly following the Effective Date, each Party shall designate, by
written notice to the other Party, a representative to facilitate communication
and coordination of the Parties’ activities under this Agreement and to provide
support and guidance to the JSC (each, a “Project Manager”).  Each Project Manager shall be experienced in
project management and may also serve as a representative of its respective
Party on the JSC.


 


ARTICLE 3

PRODUCT DEVELOPMENT


 


3.1                               Overview. 
The Parties shall Develop the Product in the Field in the Licensed
Territory as provided in this Article 3 and in accordance with mutually
agreed upon development plans, which shall set forth all Development activities
to be performed by the Parties under this Agreement.  Except as set forth in this Article 3,
3SBio shall be primarily responsible for conducting all Development activities
under this Agreement in the Licensed Territory.


 


3.2                               Initial Indication Development
Plan.  An initial plan containing a general
description of activities and timelines for Developing the Product for the
Initial Indication in the Licensed Territory (the “Initial
Indication Development Plan”) has been agreed upon by the Parties and
is attached hereto as Exhibit D
and incorporated herein by reference. 
Within ninety (90) days after the Effective Date, the Parties shall
prepare a comprehensive development plan, consistent in all material respects
with the Initial Indication Development Plan, describing the activities to be
conducted by the Parties to Develop and seek Regulatory Approval for the
Product for the Initial Indication in the Licensed Territory under this
Agreement, which plan the Parties shall submit to the JSC for review and
approval.  Upon JSC approval, such plan
shall become effective as the then-current Initial Indication Development
Plan.  From time to time, either Party
may submit to the JSC for discussion any proposed modifications to the Initial
Indication Development Plan, and the JSC shall discuss such proposed
modifications at its next meeting, and any such modification will become
effective only upon approval by the JSC as provided in Section 2.2.


 


3.3                               Additional Indications. 
AMAG shall notify the JSC of each indication (other than the Initial
Indication) for which AMAG is Developing, seeking Regulatory Approval of, or
Commercializing the Product in the U.S. (each, an “Additional
Indication”), no later than the first dosing of a patient in a Phase
III Clinical Trial for such Additional Indication anywhere in the AMAG
Territory.  Within sixty (60) days of the
JSC’s receipt of such notice, 3SBio shall notify AMAG, through its JSC
representatives, whether 3SBio agrees to Develop the Product for such
Additional Indication in the Licensed Territory.  If 3SBio does not so agree, then such
Additional Indication shall be an “Independent Indication”
and AMAG shall be solely responsible, at its discretion and expense, for
Developing and seeking Regulatory Approval of


 


11

















 


the Product for the
Independent Indication in the Licensed Territory.  3SBio shall have no rights to Develop or
Commercialize the Product in any Independent Indication without the prior
written consent of AMAG, which may be granted or withheld at AMAG’s sole
discretion, and such Independent Indication shall be excluded from the scope of
this Agreement.  If 3SBio agrees to
Develop the Product for such Additional Indication in the Licensed Territory,
then the Additional Indication shall be a “Co-Developed Indication.”  From time to time, 3SBio may propose to the
JSC that it Develop, seek Regulatory Approval of, or Commercialize the Product
in the Licensed Territory in one or more indications other than the Initial Indication
(each, a “3SBio Proposed Indication”).  Within sixty (60) days of the JSC’s receipt
of such notice, AMAG shall notify 3SBio whether AMAG agrees to permit the
Development and Commercialization of the Product for such 3SBio Proposed
Indication in the Licensed Territory in accordance with the terms of this
Agreement, which agreement may be granted or withheld at AMAG’s sole
discretion.  If AMAG so agrees, then the
3SBio Proposed Indication shall be a “Co-Developed Indication.”  If AMAG does not so agree, then 3SBio shall
have no rights to Develop, seek Regulatory Approval of or Commercialize the
Product in such 3SBio Proposed Indication without the prior written consent of
AMAG, which may be granted or withheld at AMAG’s sole discretion.  With respect to each Co-Developed Indication,
the Parties shall prepare a comprehensive development plan describing the
activities to be conducted by the Parties to Develop and seek Regulatory
Approval for the Product for the Co-Developed Indication in the Licensed Territory
under this Agreement, and a Budget for all such activities (each, an “Additional Indication Development Plan”).  Unless the JSC has earlier been notified
pursuant to this Section 3.3, AMAG shall notify the JSC of each Product
(as defined in Section 1.54(b)) for which AMAG has submitted an MAA to the
FDA for the Initial Indication or any Co-Developed Indication, within sixty
(60) days after the later of (i) such submission or (ii) the adoption
of the applicable Co-Developed Indication under this Section 3.3.  Promptly after such notification, the Parties
shall prepare amendments to the applicable Development Plan to include
Development activities for such Product and shall submit such amendments to the
JSC for approval.  Unless the JSC
determines otherwise, the allocation of activities and expenses for each
Co-Developed Indication and Product shall be as set forth in Sections 3.4 and
3.7.  From time to time, either Party may
submit to the JSC for discussion any proposed modifications to an Additional Indication
Development Plan, and the JSC shall discuss such proposed modifications at its
next meeting, and any such modification will become effective only upon
approval by the JSC as provided in Section 2.2.


 


3.4                               Specific Development Activities. 
As further described in the Initial Indication Development Plan and each
Additional Indication Development Plan (collectively, the “Development
Plans”), the Parties’ responsibilities for conducting Development of
the Product in the Field in the Licensed Territory shall be allocated as
follows:


 


(a)                                  Initial Indication. 
3SBio shall be responsible, at its sole expense, for conducting: (i) those
clinical studies described in the Initial Indication Development Plan,
including [***], and (ii) any
and all other studies required by the Regulatory Authorities in the


 






[***] INDICATES MATERIAL
THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED.
ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT
OF 1934, AS AMENDED.


 


12

















 


Licensed Territory for
Regulatory Approval of the Product for the Initial Indication in the Licensed
Territory ((i) and (ii), collectively, the “Initial
Indication Studies”).  The
Initial Indication Studies will be conducted in accordance with clinical
protocols approved by the JSC pursuant to Section 2.2(a)(iv) and
shall be conducted in the Licensed Territory.


 


(b)                                  Co-Developed Indications. 
3SBio shall be responsible for conducting: (i) clinical proof of
concept studies of the Product related to any Co-Developed Indication, [***], (ii) for each Co-Developed
Indication, Phase II Clinical Trials of the Product that are required by the Regulatory
Authorities in the Licensed Territory for Regulatory Approval of the Product
for such Co-Developed Indication in the Licensed Territory, [***], and (iii) for each Co-Developed
Indication, Phase III Clinical Trials (the “Co-Developed Indication Phase
III Clinical Trials”) of the Product that are required by the
Regulatory Authorities in the Licensed Territory for Regulatory Approval of the
Product for such Co-Developed Indication in the Licensed Territory ((ii) and
(iii), collectively, the “Co-Developed Indication
Clinical Studies”).  Each
Co-Developed Indication Phase III Clinical Trial shall be funded [***]. 
Each Co-Developed Indication Clinical Study shall be conducted by 3SBio
or on its behalf using a local contract research organization in the Licensed
Territory.  Each such local contract
research organization shall coordinate its activities with and will be managed
by AMAG’s global contract research organization that is conducting clinical
trials on behalf of AMAG in the AMAG Territory. 
Before entering into an agreement with any local contract research
organization, 3SBio shall present the qualifications and capabilities of such
local contract research organization to the JSC for discussion and approval of
such organization.


 


(c)                                  Post-Approval Trials. 
3SBio shall be responsible, [***], for conducting in the Licensed
Territory any and all Phase IV Clinical Trials of the Product in the Field.


 


3.5                               Principles of Product
Development.  3SBio’s Development of the Product in the
Field in the Licensed Territory shall be conducted in a manner consistent with
the following principles:


 


(a)                                  seeking Regulatory Approvals that include
a broad label for the Product;


 


(b)                                  seeking a product profile for the Product
with maximum scope of recommended usage and minimum scope of restrictions on
use;


 


(c)                                  obtaining Regulatory Approvals for the
Product consistent with (a) and (b) in a timely manner; and


 


(d)                                  not adversely impacting AMAG’s own
development or commercialization efforts for the Product in the AMAG Territory
or outside the Field.


 






[***] INDICATES MATERIAL
THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED.
ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT
OF 1934, AS AMENDED.


 


13

















 


3.6                               The Parties’ Performance. 
3SBio shall devote Diligent Efforts to Develop and obtain Regulatory
Approval for the Product under this Agreement in the Licensed Territory, in all
cases consistent with the then-agreed upon Development Plans and in accordance
with this Agreement.  AMAG shall devote
Diligent Efforts to perform all activities allocated to AMAG in the then-agreed
upon Development Plans in accordance with this Agreement.  The Parties shall conduct their activities
under the Development Plans using appropriate scientific practices and in
compliance in all material respects with all applicable Laws.  3SBio may not conduct any Development
activities that are not set forth in one of the Development Plans or that are
inconsistent with this Agreement without AMAG’s prior written consent.


 


3.7                               Development Costs.  3SBio shall be solely responsible for all costs
associated with the Development of the Product for the Initial Indication in
the Licensed Territory, including without limitation (i) all costs
associated with the Initial Indication Studies and (ii) all Regulatory
Fees for the Initial Indication in the Licensed Territory.  The Parties [***]. 
If either Party incurs or anticipates incurring Out-of-Pocket Costs for
the Co-Developed Indication Clinical Studies that exceed the applicable amount
set forth in the Budget, such Party shall so notify the JSC.  The JSC shall discuss and determine the
allocation between the Parties of such Budget overruns, which may include
amending the Budget; provided, that
each Party shall continue to conduct its activities set forth in the applicable
Development Plan, and the Party incurring Budget overruns may thereafter seek
reimbursement for such activities.  The
JSC shall act promptly to address the issue of Budget overruns, and nothing in
this Section 3.7 shall require a Party to [***] or to continue activities in connection
with Co-Developed Indication Phase III Clinical Trials for more than thirty
(30) days in the event of a Budget overrun, if the other Party’s
representatives to the JSC have not acted to address the overrun in such time.


 


3.8                               Records, Reports and Information.  Each Party shall maintain
complete, current and accurate records of all work conducted by it under the
Development Plans and all data and other Information resulting from such
work.  Such records shall fully and
properly reflect all work done and results achieved in the performance of the
Development Plans in sufficient detail and in good scientific manner
appropriate for patent and regulatory purposes. 
Each Party shall have the right to review such records maintained by the
other Party at reasonable times, upon written request.  Each Party shall provide written reports to
the JSC on its Development and regulatory activities with the Product in the
Licensed Territory, including without limitation any informal meetings between
such Party and a Regulatory Authority in the Licensed Territory, on a quarterly
basis at the end of each calendar quarter, at a level of detail reasonably
sufficient, in the case of 3SBio, to enable AMAG to determine 3SBio’s
compliance with its diligence obligation pursuant to Section 3.6.  All such Information and reports shall be the
Confidential Information of AMAG.


 






[***] INDICATES MATERIAL
THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED.
ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT
OF 1934, AS AMENDED.


 


14
















 


ARTICLE 4

REGULATORY MATTERS


 


4.1                               Transfer of Data.


 


(a)                                  AMAG Regulatory Dossier. 
Within thirty (30) days after the Effective Date, AMAG shall provide
3SBio with a copy of all MAAs and other Regulatory Materials submitted by AMAG
to the FDA in support of its Investigational New Drug Application, Drug Master
File and New Drug Application for the Product in the Initial Indication (the “Dossier”), in each case only as necessary to secure
Regulatory Approval in the Licensed Territory. 
The Dossier shall be the Confidential Information of AMAG.  The Parties, through their representatives to
the JSC, shall discuss the use, disclosure, and protection of Information
included in the Dossier, including without limitation any CMC information.  3SBio may use the Dossier in its Regulatory
Materials only to the extent expressly authorized in writing by AMAG, not to be
unreasonably withheld or delayed.


 


(b)                                  Data Generated by or on Behalf of
the Parties.  Each Party shall, in a timely manner and
compliant with the reporting requirements of Regulatory Authorities in the
Licensed Territory, provide the other Party with copies of all preclinical,
non-clinical and clinical data generated by such Party or on behalf of such
Party by any Third Party for the Licensed Territory under this Agreement, after
the Effective Date on a quarterly basis; provided, that
information regarding adverse events and serious adverse events shall be
provided promptly as set forth in Section 4.6.


 


(c)                                  Use of Data.  All preclinical, non-clinical, analytical, and
clinical data and associated reports generated by 3SBio under this Agreement
shall be owned solely by AMAG and shall be AMAG’s Confidential Information
(notwithstanding anything in this Agreement to the contrary).  Except as otherwise
provided in this Agreement, 3SBio may use such data solely for the purpose of
Developing the Product and seeking and obtaining Regulatory Approval of and
Commercializing the Product in the Field in the Licensed Territory, subject to Article 12.  Without otherwise limiting its rights under
this Agreement, AMAG shall have the right to share any and all such data and
other Regulatory Materials received from 3SBio with Regulatory Authorities and
with AMAG’s Affiliates and Third Party licensees in the AMAG Territory.


 


4.2                               Regulatory Filings and
Approvals.


 


(a)                                  In General. 
The Parties intend that the Development Plans will set forth the agreed
regulatory strategy for seeking Regulatory Approval of the Product in the Field
in the Licensed Territory.  Except as
provided in Section 4.2(b), 3SBio shall be responsible, in consultation
with AMAG through the JSC, for preparing any and all Regulatory Materials to be
used for filing with Regulatory Authorities in the Licensed Territory, and for
filing Marketing Authorization Applications, Pricing Approval applications and
all other applications in connection with seeking Regulatory Approvals for the
Product in the Field in the Licensed Territory in the Initial Indication and
all Co-Developed Indications.


 


(b)                                  Manufacturing. 
AMAG shall be primarily responsible, at its expense and as required by
any Regulatory Authority for the Licensed Territory, for the preparation of any


 


15

















 


components of Regulatory
Materials to be filed by 3SBio in the Licensed Territory that relate to the
Manufacture of the Product.  3SBio shall
be primarily responsible for communicating with Regulatory Authorities in the
Licensed Territory regarding Manufacture of the Product for the Licensed
Territory, provided that 3SBio shall not disclose
any CMC Information without AMAG’s prior written approval of the form and
content of such disclosure, and if 3SBio receives a communication or request
for a meeting from any Regulatory Authority in the Licensed Territory regarding
Manufacture of the Product, 3SBio shall promptly notify AMAG, and AMAG shall
have the right to attend any such meeting, in accordance with Section 4.2(e)(i),
and to review, comment on, and approve any proposed response to the Regulatory
Authority.  Upon prior notice to 3SBio
and subject to 3SBio’s consent, not to be unreasonably withheld or delayed,
AMAG shall have the right to communicate with Regulatory Authorities in the
Licensed Territory regarding Manufacture of the Product for the Licensed Territory.  3SBio shall cooperate with AMAG and AMAG’s
representatives and take such actions as AMAG may reasonably request in
connection with the foregoing activities and communications as necessary to
protect the CMC Information and all other Confidential Information related to
the Manufacture of the Product for the Licensed Territory.


 


(c)                                  KOL Meeting. 
As commercially appropriate for the Development and Commercialization of
the Product in the Licensed Territory, 3SBio shall conduct one or more meetings
with nephrology key opinion leaders to discuss medical and regulatory strategy
for the Product in the Licensed Territory. 
3SBio shall provide prior notice to AMAG of such meetings, and AMAG
shall have the right to attend such meetings. 
Promptly after each meeting, 3SBio shall provide the JSC with a report
in English summarizing the meeting.


 


(d)                                  Rights of Reference to
Regulatory Materials.  Each
Party hereby grants to the other Party a right of reference to all Regulatory
Materials filed by such Party in its respective territory for the Product in
the Field as follows: AMAG
and Affiliates shall have the right to cross-reference any and all data and
other Regulatory Materials generated by 3SBio under this Agreement with respect
to the Product in AMAG’s MAAs and other Regulatory Materials submitted to
Regulatory Authorities in the AMAG Territory, for any indication.  3SBio shall have the right to cross-reference
any and all data and other Regulatory Materials generated by AMAG with respect
to the Product in 3SBio’s MAAs and other Regulatory Materials submitted to
Regulatory Authorities in the Licensed Territory, solely for the purpose of
obtaining Regulatory Approval for the Product in the Field for the Initial
Indication and all Co-Developed Indications in the Licensed Territory, subject
to Section 4.1(a).


 


(e)                                  3SBio’s Rights and
Obligations.


 


(i)                                    Except as set forth in Section 4.2(b),
3SBio shall have the sole right and responsibility for preparing, submitting
and maintaining Regulatory Materials in the Licensed Territory and for seeking
Regulatory Approval for the Product in the Field in the Licensed Territory in
the Initial Indication and all Co-Developed Indications.  As part of the foregoing, 3SBio shall be
responsible for seeking any necessary approvals of Regulatory Authorities for
Product Labeling and Promotional Materials to be used in the Licensed Territory
in connection with Commercializing the Product in the Initial Indication and
all Co-Developed Indications.  Upon request
of AMAG, 3SBio shall allow at least one AMAG representative to


 


16

















 


attend all meetings with
Regulatory Authorities in the Licensed Territory regarding the Product in the
Initial Indication and all Co-Developed Indications, and 3SBio shall inform
AMAG sufficiently in advance of any such meetings scheduled.


 


(ii)                                3SBio shall use Diligent Efforts in
compliance with applicable Laws and other regulatory obligations related to
Development and Regulatory Approval in the Licensed Territory, to prepare and
file the appropriate Regulatory Materials and to seek to obtain Regulatory
Approval for the Product in the Initial Indication and all Co-Developed
Indications as soon as practicable.


 


(iii)                            All MAAs, Regulatory Materials and
Regulatory Approvals for the Product in the Initial Indication and all
Co-Developed Indications filed with Regulatory Authorities in the Licensed
Territory shall be held in 3SBio’s name and shall be owned solely by 3SBio,
subject to AMAG’s rights under this Agreement.


 


(f)                                    Reporting and
Review.  3SBio shall provide AMAG with copies of any proposed
Regulatory Materials regarding the Product in the Initial Indication and all
Co-Developed Indications sufficiently in advance of the intended submission to
Regulatory Authorities and shall reasonably consider AMAG’s comments thereto to
the extent practicable; provided,
that 3SBio shall not submit any Regulatory Materials that relate specifically
to the Manufacture of the Product without AMAG’s prior approval of such
Regulatory Materials.  3SBio shall
consult with AMAG, through the JSC, regarding, and keep AMAG reasonably and
regularly informed of, the preparation of all Regulatory Materials, Regulatory
Authority review of Regulatory Materials, and Regulatory Approvals for the
Product in the Initial Indication and all Co-Developed Indications in the
Licensed Territory.  3SBio shall provide
AMAG with copies of all Regulatory Approvals it receives for the Product in the
Initial Indication and all Co-Developed Indications in the Licensed Territory
promptly after receipt thereof.


 


4.3                               Regulatory
Expenses.  3SBio shall be responsible for all costs
and expenses of preparing, maintaining, formatting, and filing Regulatory
Materials for the Product in the Initial Indication and all Co-Developed Indications
in the Licensed Territory, including without limitation all Regulatory Fees,
and for all other costs and expenses in connection with seeking and maintaining
Regulatory Approval for the Product in the Initial Indication and all
Co-Developed Indications in the Licensed Territory; provided,
that AMAG shall be solely responsible for all costs and expenses of its
activities under Section 4.2(b); and provided,
further, that 3SBio shall be solely responsible for all Out-of-Pocket Costs
associated with any inspections of AMAG’s manufacturing facilities or the
facilities of any of AMAG’s contract manufacturers by 3SBio or the SFDA in the
Licensed Territory.


 


4.4                               Communications. 
Except as required by Law or pursuant to Section 4.2(b), AMAG shall
not communicate regarding the Product with respect to the Initial Indication or
any Co-Developed Indication with any Regulatory Authority having jurisdiction
in the Licensed Territory unless explicitly requested or permitted in writing
to do so by 3SBio or unless so ordered by such Regulatory Authority in the
Licensed Territory, in which case AMAG shall provide 3SBio prompt notice of
such order.  Except as may be required by
law, 3SBio shall not communicate with any Regulatory Authority having
jurisdiction outside the Licensed Territory regarding the Product unless
explicitly requested or permitted in writing to do so by AMAG, or


 


17

















 


unless so ordered by such
Regulatory Authority, in which case 3SBio shall provide immediately to AMAG
notice of such order.


 


4.5                               No
Harmful Actions.  3SBio shall not take any action
with respect to the Product in the Licensed Territory that could reasonably be
expected to have a material adverse impact upon the regulatory status or
potential sales of the Product outside the Licensed Territory.  If AMAG believes that 3SBio is taking or
intends to take any action that could reasonably have such an impact, AMAG
shall bring the matter to the attention of the JSC.  The JSC shall discuss whether any such action
that either Party brings to the JSC’s attention reasonably would have such an
impact, and potential alternative courses of action that 3SBio could take to
avoid such an impact.  If the JSC cannot
reach agreement as to such matters, then either Party may refer such matters
for resolution pursuant to Section 14.2. 
Furthermore, 3SBio will use commercially reasonable efforts to preserve
the existence and breadth of any Regulatory Approvals for the Product obtained
in the Licensed Territory in the course of reexamination, reevaluation and
other post marketing surveillance review procedures required by the SFDA.


 


4.6                               Adverse Event Reporting
and Safety Data Exchange.  The Parties agree that 3SBio will be
primarily responsible for the monitoring of all clinical experiences and filing
of all required reports with Regulatory Authorities in the Licensed Territory
throughout clinical Development and Commercialization of the Product in the
Licensed Territory; provided, that
3SBio shall provide AMAG with copies of all such required reports with a
summary in English at the same time such reports are transmitted to the
relevant Regulatory Authorities. The parties also agree that AMAG shall be
solely responsible for maintaining the global safety database with respect to
the Product and shall provide 3SBio with all relevant information as requested
from such global safety database as necessary to comply with Regulatory
Authorities in the Licensed Territory. 
Specific details regarding the disclosure and management of information
of adverse events related to the use of the Product in the Licensed Territory
will be delineated in a separate pharmacovigilance agreement that shall be
agreed to by the Parties within ninety (90) days after the Effective Date.


 


4.7                               Regulatory Authority
Communications.


 


(a)                                  3SBio Disclosures to AMAG.


 


(i)                                    General. 
3SBio shall provide AMAG with copies of (A) all correspondence it
receives from or submits to Regulatory Authorities in the Licensed Territory
that relate to Regulatory Approval of the Product in the Licensed Territory,
promptly after receipt or submission (as applicable) thereof; (B) minutes
of all meetings related to the Product with Regulatory Authorities in the
Licensed Territory; and (C) all other material correspondence it receives
from or submits to Regulatory Authorities in the Licensed Territory under this
Agreement, in each case promptly after receipt, preparation or submission (as
applicable) thereof.


 


(ii)                                Specific Disclosures. 
Without limiting the generality of the foregoing, 3SBio shall keep AMAG
informed, in a timely manner compliant with the reporting requirements of
Regulatory Authorities in the Licensed Territory of notification of any action
by, or notification or other information that it receives (directly or indirectly)
from, any Regulatory


 


18

















 


Authority in the Licensed
Territory that:  (1) raises any
material concerns regarding the safety or efficacy of the Product; (2) indicates
or suggests a potential material liability of either Party to Third Parties in
connection with the Product; (3) is reasonably likely to lead to a recall
or market withdrawal of the Product; or (4) relates to expedited and
periodic reports of adverse events with respect to the Product, or Product
Complaints, and that may have a material impact on Regulatory Approval or the
continued Commercialization of the Product.


 


(iii)                            Regulatory Actions and Regulatory
Non-Compliance.  In addition to its obligations under
subsections (i) and (ii), 3SBio shall promptly disclose to AMAG the
following information:


 


(1)                                 All material information pertaining to
actions taken by Regulatory Authorities in connection with the Product (and/or
its testing, distribution and/or facilities connected thereto) including, without
limitation, any notice, audit notice, notice of initiation by Regulatory
Authorities of investigations, inspections, detentions, seizures or injunctions
concerning the Product (and/or its distribution, and/or facilities connected
thereto), notice of violation letter (i.e., an
untitled letter), warning letter, service of process or other inquiry; and


 


(2)                                 All information pertaining to notices
from Regulatory Authorities of non-compliance with Laws in connection with the
Product including, without limitation, receipt of a warning letter or other
notice of alleged non-compliance from any Regulatory Authority relating to the
Product.


 


(b)                                  AMAG Disclosures to 3SBio. 
AMAG shall keep 3SBio informed, in a timely manner compliant with the
reporting requirements of Regulatory Authorities in the Licensed Territory or
the AMAG Territory, as applicable, of notification of any action by, or
notification or other information that it receives (directly or indirectly)
from, any Regulatory Authority in the Licensed Territory or the AMAG Territory
that: (1) raises any material concerns regarding the safety or efficacy of
the Product; (2) is reasonably likely to lead to a recall or market
withdrawal of the Product; or (3) relates to expedited and periodic
reports of adverse events with respect to the Product, or Product Complaints,
and that may have a material impact on Regulatory Approval or the continued
Commercialization of the Product.  In
addition, AMAG shall keep 3SBio informed, in a timely manner compliant with the
reporting requirements of Regulatory Authorities in the Licensed Territory, of
notification of any action by, or notification or other information that it
receives (directly or indirectly) from, any Regulatory Authority in the
Licensed Territory that indicates or suggests a potential material liability of
either Party to Third Parties in connection with the Product.


 


(c)                                  Territory-Specific
Obligations.  In addition to the obligations set forth
in Sections 4.7(a) and 4.7(b), if AMAG receives any communication or
questions from any Regulatory Authority in the Licensed Territory, or if 3SBio
receives any communication or questions from any Regulatory Authority in the
AMAG Territory, relating to matters set forth in Sections 4.7(a)(ii) and
4.7(b), the receiving Party shall notify the other Party as soon as possible
(but in no event later than two (2) business days after receipt of such
notice or inquiry) and provide to such other Party copies of all documents, if
any, it received from such Regulatory Authorities.  Such other Party will then prepare the
response to the communication.  Before


 


19

















 


submitting such response
to a Regulatory Authority regarding the communication, the Party that
originally received the communication will have an opportunity to comment on
the response to the extent such response may affect its rights or obligations
under this Agreement.  The other Party
will fully cooperate with and assist such Party in complying with all such
regulatory obligations and communications, including by providing to such
Party, within forty-eight (48) hours after a request, such information and
documentation in the other Party’s possession as may be necessary or helpful
for the Party to prepare a response to an inquiry from a Regulatory
Authority.  If 3SBio is required to
respond to any Regulatory Authority in the AMAG Territory, or if AMAG is
required to respond to any Regulatory Authority in the Licensed Territory for
the Initial Indication or any Co-Developed Indication, the responding Party
shall make diligent efforts to seek the input and approval of the other Party
before responding.  Each Party will also
provide the other Party in a timely manner with a copy of all correspondence
received from a Regulatory Authority specifically regarding the matters
referred to above.


 


(d)                              Form of Communications. 
All communications that are required to be provided by 3SBio to AMAG
pursuant to this Section 4.7 shall, to the extent such communications are
not written in English, be accompanied by an executive summary written in
English that identifies the communication, the date thereof, the identities of
the party from whom the communication originated and the party to whom the
communication was addressed, and the material contents of such communication,
and such other information as is reasonably necessary to allow AMAG to
understand the material contents of such communication.


 


4.8                               Regulatory Inspection or
Audit.  If a Regulatory Authority desires to conduct an
inspection or audit of 3SBio’s facility or a facility under contract with 3SBio
with regard to the Product in the Licensed Territory, then 3SBio shall
cooperate and cause the contract facility to cooperate with such Regulatory
Authority during such inspection or audit, and 3SBio shall be solely
responsible for all costs associated with any such inspection or audit.  3SBio shall provide advance notice of any
such inspection or audit to AMAG, and AMAG shall have the right to be present
at such inspection or audit at AMAG’s sole cost and expense.  Following receipt of the inspection or audit
observations of such Regulatory Authority (a copy of which 3SBio will
immediately provide to AMAG), 3SBio will provide a proposed response to any such
observations to AMAG for review and comment, and shall consider AMAG’s comments
in good faith.  3SBio agrees to conform
its activities under this Agreement to any commitments made in such a response,
except to the extent it believes in good faith that such commitments violate
applicable Laws.


 


4.9                               Recalls and Voluntary Withdrawals. 
Each Party shall provide the other Party with its standard operating
procedures (“SOPs”) for conducting
product recalls reasonably in advance of the First Commercial Sale of the
Product in the Licensed Territory, and the Parties shall discuss and resolve
any conflicts between such SOPs and issues relating thereto promptly after such
exchange.  If
either Party becomes aware of information relating to any Product that
indicates that a unit or batch of Product may not conform to the specifications
therefor, or that potential adulteration, misbranding, and/or other issues have
arisen that relate to the safety or efficacy of the Product, it shall promptly
so notify the other Party.  The JSC shall
meet to discuss such circumstances and to consider appropriate courses of
action, which shall be consistent with the internal SOP of the Party having the
right to control such recall pursuant to this Section 4.9.


 


20

















 


3SBio shall have the
right, at its expense, to control any product recall, field correction, or
withdrawal of the Product in the Licensed Territory.  As between the Parties, AMAG shall have the
right, at its expense, to control all recalls, field corrections, and withdrawals
of the Product in the AMAG Territory. 
3SBio shall maintain complete and accurate records of any recall in the
Licensed Territory for such periods as may be required by applicable Laws, but
in no event for less than three (3) years.


 


ARTICLE 5

COMMERCIALIZATION


 


5.1                               Commercialization in the Licensed
Territory.  3SBio shall have sole responsibility for
Commercializing the Product in the Field in the Licensed Territory solely in
the Initial Indication and each Co-Developed Indication, as provided in this Article 5,
in accordance with a detailed marketing plan for the Initial Indication and for
each Co-Developed Indication that sets forth 3SBio’s responsibilities with
respect to, and budget and promotional strategy for, Commercialization of the
Product in the Licensed Territory (each, a “Marketing Plan”).  At least twelve (12) months prior to the date
the JSC anticipates obtaining the first Regulatory Approval for the Product for
the Initial Indication and each Co-Developed Indication in the Licensed Territory,
3SBio shall prepare the initial Marketing Plan for the Initial Indication or
applicable Co-Developed Indication and submit it to the JSC for review and
approval.  As part of its preparation of
the Marketing Plan for the Initial Indication, 3SBio shall conduct a market
survey of the Product for use in the Initial Indication in the Licensed
Territory.  On at least an annual basis,
3SBio shall update and amend, as appropriate, each then-current Marketing Plan.  3SBio shall submit all proposed updates and amendments
to the Marketing Plans to the JSC for review and comment, and the JSC shall
approve or disapprove such updates and amendments at its next meeting.  3SBio shall bear all costs and expenses it
incurs in connection with preparing the Marketing Plans and with all such
Commercialization.


 


5.2                               Affiliates and Distributors. 
3SBio shall provide the JSC with prior written notice of any and all
Affiliates and distributors performing any Commercialization activities on
behalf of 3SBio, and shall identify each such Affiliate and distributor and the
activities performed by such Affiliates and distributors in the Marketing
Plan.  The Marketing Plan shall contain a
description of all transfer pricing arrangements between 3SBio and its
Affiliates.


 


5.3                               Pricing Approvals in the
Licensed Territory.  3SBio shall be responsible, at its own
expense, for seeking Pricing Approval for the Product in the Licensed
Territory, as set forth in the Marketing Plan. 
3SBio shall keep AMAG informed on an ongoing basis of 3SBio’s strategy
for seeking, and the results it obtains in seeking, Pricing Approval in the
Licensed Territory, including, without limitation, the results of any
discussion or other communication with relevant Governmental Authorities
regarding Pricing Approval, via regular reports to the JSC no less frequently
than such committee is required to meet pursuant to Section 2.2.


 


5.4                               Pricing of the Product
in the Licensed Territory.  The Parties,
through the JSC, shall discuss the pricing and reimbursement strategies for the
Product in the Licensed Territory. 
However, 3SBio
shall have the sole right to determine all pricing of the Product in the
Licensed Territory.  Notwithstanding
anything in this Agreement express or implied to the contrary, AMAG shall not
have any right to direct, control, or approve 3SBio’s pricing of the Product
for


 


21

















 


the Licensed
Territory.  The provision to AMAG of any
pricing data in connection with the Marketing Plan is for informational purposes
only.


 


5.5                               3SBio
Performance.


 


(a)                                  Commercial
Diligence.  3SBio shall devote Diligent Efforts to
Commercializing the Product in the Field in the Licensed Territory following
each Regulatory Approval of the Product in the Licensed Territory for the Initial
Indication and the Co-Developed Indications in accordance with this
Agreement.  Without limiting the
generality of the foregoing, and subject to timely supply by AMAG pursuant to Article 7
and the Supply Agreement, 3SBio shall achieve First Commercial Sale of the
Product in the Licensed Territory promptly after, and in any case not later
than two (2) months after, the date on which the SFDA grants approval of
the MAA for the Product in the Initial Indication and each Co-Developed
Indication in the Licensed Territory and shall file the appropriate Regulatory
Materials and seek to obtain Pricing Approval for the Product as soon as
practicable.


 


(b)                                  Details. 
Without limiting the generality of the first sentence of Section 5.5(a),
3SBio shall provide for a sales force of at least [***] Sales Representatives specializing in
nephrology to promote the Product for the Initial Indication with Primary
Position Details in the Licensed Territory. 
To the extent practical, 3SBio will use its Affiliates’ existing sales
force for erythropoiesis-stimulating agents to perform such promotion for the
Initial Indication in combination with other 3SBio sales representatives that
it reasonably determines have the most relevant expertise and qualification to
Detail the Product in the Licensed Territory. 
The Marketing Plan for the Initial Indication and each Co-Developed
Indication will include more specific information regarding the size and
distribution of such sales force and the Detailing requirements for the
applicable indication.  3SBio shall not
use any Third Parties to perform promotional activities for the Product in the
Licensed Territory without the prior written approval of AMAG.  If AMAG grants such approval, such Third
Parties shall be trained in accordance with Section 5.9.  All Sales Representatives who will be
performing Details shall be assigned their responsibilities, activities, Sales
Calls territory and Detail requirements by 3SBio in accordance with the
then-current Marketing Plan.


 


(c)                                  Reports. 
3SBio
shall update the JSC periodically regarding 3SBio’s Commercialization
activities with the Product in the Field in the Licensed Territory.  In addition, 3SBio shall present a written
report each year summarizing 3SBio’s Commercialization activities with respect
to the Product in the Field in the Licensed Territory pursuant to this
Agreement, covering subject matter at a level of detail reasonably requested by
AMAG and sufficient to enable AMAG to determine 3SBio’s compliance with its
diligence obligations pursuant to this Section 5.5.  Such reports shall include a description of
all transfer pricing arrangements between 3SBio and its Affiliates with respect
to the Product.


 






[***] INDICATES MATERIAL
THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED.
ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT
OF 1934, AS AMENDED.


 


22
















 


5.6                               Compliance. 
3SBio shall comply in all material respects with all applicable Laws and
guidelines in Developing and Commercializing Products in the Licensed Territory
under this Agreement, including without limitation the Foreign Corrupt
Practices Act of 1977, as amended (“FCPA”).  3SBio represents, warrants and covenants to
AMAG that, as of the Effective Date, 3SBio and its Affiliates have adequate
procedures in place: (i) to ensure their compliance with the FCPA; (ii) to
bring any noncompliance therewith by any of the foregoing entities to 3SBio’s
attention; and (iii) to promptly remedy any such noncompliance.


 


5.7                               Product Trademarks and
House Marks.


 


(a)                                  Product Trademarks.  The JSC shall determine the Product-related
trademarks to be used in connection with Commercializing the Product in the
Licensed Territory, and shall give due consideration to the AMAG Product
Marks.  If 3SBio determines that a trademark different from or
in addition to the AMAG Product Marks would increase the likelihood of commercial
success of the Product in the Licensed Territory, then 3SBio shall submit a
proposed trademark to the JSC for review, comment, and approval.  Subject to JSC approval, the Marketing Plan
shall be amended to include any such new trademarks.  3SBio shall own all right, title, and
interest in and to all trademarks developed by either Party under this
Agreement after the Effective Date for use in connection with Commercializing
the Product in the Licensed Territory, other than any AMAG Product Mark (the “New Product Marks”). 
3SBio shall be solely responsible, at its expense, for filing,
prosecuting, and maintaining the New Product Marks.   AMAG shall be solely responsible, at its
expense, for filing, prosecuting, and maintaining the AMAG Product Marks.


 


(b)                                  House Marks. 
To the extent allowable by applicable Law, Product packaging,
Promotional Materials and Product Labeling for use in the Licensed Territory
shall carry, in a conspicuous location, (i) one or more of the AMAG House
Marks, subject to 3SBio’s reasonable approval of the size, position, and
location thereof, and (ii) at 3SBio’s sole discretion, one or more of
3SBio’s trademarks or tradenames (the “3SBio
Marks”).  The Parties agree
that the JSC shall determine the display of the 3SBio Marks along with the AMAG
House Marks under a general principle of co-prominence.  AMAG shall own all right, title and interest
in the AMAG House Marks and shall be solely responsible, at its expense, for
filing, prosecuting, and maintaining the AMAG House Marks.  3SBio shall own all right, title and interest
in the 3SBio Marks and shall be solely responsible, at its expense, for filing,
prosecuting, and maintaining the 3SBio Marks.


 


(c)                                  Inspection. 
From time to time during the Term, AMAG shall have the right to obtain from
3SBio samples of the final finished Product sold by 3SBio or its Affiliates or
permitted sublicensees in the Licensed Territory.  AMAG shall use such Product samples solely to
inspect the quality of such Products and use of the AMAG Marks.


 


(d)                                  No Inconsistent Acts. 
3SBio acknowledges the sole ownership of the AMAG Product Marks by
AMAG.  3SBio agrees that it will do
nothing inconsistent with such ownership, and that any goodwill arising through
use of the AMAG Product Marks by 3SBio shall inure to the benefit of AMAG.  3SBio agrees
that it will not at any time during or after the Term assert or claim any
interest in or do anything that may adversely affect the validity or
enforceability of any AMAG Product Mark. 
Further, if requested by AMAG, 3SBio shall


 


23

















 


execute all trademark
registered user agreements that are submitted by AMAG to protect AMAG’s title
in the AMAG Product Marks.  3SBio agrees
that it shall not register, seek to register or cause to be registered, or seek
to obtain ownership of, any AMAG Product Mark or New Product Mark (other than
in the Licensed Territory), any variation thereof, or any mark similar thereto
in any jurisdiction in any language. 
3SBio further agrees that it shall not apply for registration or seek to
obtain ownership of any domain name incorporating any AMAG Product Mark or New
Product Mark (other than in the Licensed Territory) or any mark similar thereto
in any jurisdiction.  3SBio agrees to use
each AMAG Product Mark in accordance with trademark usage guidelines provided
by AMAG from time to time during the Term.


 


5.8                               Promotional Materials.


 


(a)                                  Development and Approval. 
Prior to the First Commercial Sale of the Product for the Initial
Indication or any Co-Developed Indication in the Licensed Territory, 3SBio
shall develop the Promotional Materials with the guidance of AMAG, through its
representatives to the JSC, which may include, upon 3SBio’s request, providing
to 3SBio corresponding promotional materials used by AMAG in the AMAG Territory
(the “AMAG Materials”).  AMAG hereby grants to 3SBio the right, during
the Term, to use and create derivative works of the AMAG Materials, solely to
the extent necessary or useful to create Promotional Materials as approved by
AMAG.  3SBio shall use the AMAG Materials
solely in preparing the Promotional Materials and for no other purpose.  In addition, 3SBio shall submit any newly
developed Promotional Materials to the JSC for review and approval.  AMAG, through its JSC representatives, shall
review all Promotional Materials for consistency with the AMAG Materials and
other AMAG promotional, training and advertising materials.  3SBio shall not use in its Commercialization
efforts any Promotional Materials without the prior written consent of AMAG,
not to be unreasonably withheld, conditioned, or delayed.  Once approved by AMAG, the Promotional
Materials shall be used solely in connection with the Commercialization of the
Product under this Agreement.  3SBio
shall be solely responsible for all expenses incurred in the development and
production of Promotional Materials.


 


(b)                                  Ownership. 
The Parties expressly agree and acknowledge that the Promotional
Materials may include, without limitation, derivative works based on one or
more AMAG Materials.  AMAG shall own all
right, title, and interest in and to the AMAG House Marks, the AMAG Product
Marks, and any other intellectual property of AMAG appurtenant to the
Promotional Materials.  3SBio shall own
all right, title, and interest in and to all other intellectual property
related to the Promotional Materials, including without limitation applicable
copyrights and the New Product Marks.


 


(c)                                  Filing of Materials with
Regulatory Authorities.  3SBio shall timely file with
the relevant Regulatory Authorities in the Licensed Territory, in accordance
with all applicable Laws, all Promotional Materials required to be filed with
such Regulatory Authorities with respect to the Commercialization of the
Product in the Licensed Territory in the Initial Indication and all
Co-Developed Indications, and shall provide AMAG with copies of such filings.


 


24

















 


5.9                               Sales Force Training.


 


(a)                                  Prior to Commercial Launch. 
Prior to the First Commercial Sale of the Product in the Licensed
Territory, AMAG shall provide 3SBio with copies of all current training
material, including all amendments and revisions thereof, used by AMAG for the
purposes of marketing and selling the Product in the AMAG Territory.  3SBio  shall be
responsible for translating such training materials and training the Sales
Representatives on the Product prior to commercial launch of the Product in the
Licensed Territory; provided, that
AMAG shall provide reasonable assistance with such training, as may be mutually
agreed by the Parties.  3SBio shall be
responsible for all expenses related to such training, including travel,
lodging, meals and salary and benefits of Sales Representatives during the
training period.


 


(b)                                  After First Commercial Sale. 
After First Commercial Sale of the Product in the Licensed Territory,
3SBio shall be solely responsible, at its expense, for developing training
materials and conducting all training of the 3SBio sales force, subject to JSC
approval of Promotional Materials under Section 5.8.


 


5.10                        Policing of Trade
Channels.  AMAG
and its Affiliates shall not (i) directly or indirectly, through any
licensees, assignees, designees, agents or representatives (other than 3SBio),
market, distribute, sell, offer for sale, or import Products into countries
outside of the AMAG Territory, (ii) engage in any advertising activities
relating to Products directed primarily to customers located in countries
outside of the AMAG Territory, or (iii) solicit orders from any
prospective purchaser located in countries outside of the AMAG Territory.  3SBio and its
Affiliates shall not (i) directly or indirectly, through any
licensees, assignees, designees, agents or representatives, market, distribute,
sell, offer for sale, or import Products into countries outside of the Licensed
Territory, (ii) engage in any advertising activities relating to Products
directed primarily to customers located in countries outside of the Licensed
Territory, or (iii) solicit orders from any prospective purchaser located
in countries outside of the Licensed Territory.  If a Party receives any order
from a prospective purchaser located in a country outside of its territory,
such Party shall immediately refer that order to the other Party and shall not
accept any such order or deliver or tender (or cause to be delivered or
tendered) any Product under such order. 
If either Party has a reasonable basis to conclude that its customer,
sublicensee or distributor, or a customer, sublicensee or distributor of the
other Party, is engaged in the sale or distribution of Products outside of the
selling Party’s territory, then the selling Party shall take all reasonable
steps (including without limitation cessation of sales to such customer)
necessary to limit such sale or distribution outside such Party’s territory.


 


ARTICLE 6

LICENSES AND EXCLUSIVITY


 


6.1                               License to 3SBio under
Collaboration Patents and AMAG Know-How. 
Subject to
the terms and conditions of this Agreement, AMAG hereby grants 3SBio an
exclusive, royalty-bearing license under the Collaboration Patents and the AMAG
Know-How to Develop (solely to the extent set forth in a Development Plan),
obtain Regulatory Approval for and Commercialize (solely to the extent set
forth in a Marketing Plan) the Product in the Initial Indication and the
Co-Developed Indications in the Licensed Territory in the Field.  The license granted in this Section 6.1:
(a) excludes the right to conduct any research or development of the
Product that is not set forth in a Development Plan, or to conduct any
Commercialization


 


25

















 


activities not set forth
in a Marketing Plan, and (b) may be sublicensed by 3SBio to an Affiliate
of 3SBio or to a Third Party only with the prior written consent of AMAG, which
consent shall not be unreasonably withheld or delayed.


 


6.2                               Limited License for AMAG House Marks and AMAG Product Marks. 
Subject to the terms of this Agreement, AMAG hereby grants to 3SBio (a) a
non-exclusive, royalty-free license within the Licensed Territory to use and
display the AMAG House Marks, and (b) an exclusive, royalty-free, license
within the Licensed Territory to use and display the AMAG Product Marks, in
each case solely in the Promotional Materials and the Product Labeling in
connection with the Commercialization of the Product in the Initial Indication
and the Co-Developed Indications in the Field in the Licensed Territory, as
provided under and in accordance with this Agreement.  The
foregoing licenses may be sublicensed by 3SBio to Affiliates or Third Party
sublicensees under the license granted in Section 6.1 that are approved by
AMAG in accordance with Section 6.1.


 


6.3                               AMAG Retained Rights.  Notwithstanding anything to the contrary in
this Agreement, and without limiting the generality of Section 6.5, AMAG
retains the right to Manufacture and have Manufactured the Product worldwide,
and to use, sell, offer for sale, import and Develop the Product (a) in
the Licensed Territory outside the Field, (b) in all Independent
Indications in the Licensed Territory, and (c) in the AMAG Territory for
all uses.  For clarity, AMAG retains all
rights worldwide to the Product, the Collaboration Patents, and the AMAG
Know-How for imaging, diagnostic, and all other non-therapeutic applications.


 


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


 


6.5                               No Implied Licenses. 
Except as explicitly set forth in this Agreement, neither Party grants
any license, express or implied, under its intellectual property rights to the
other Party.  Without limiting the
foregoing, 3SBio shall have no right hereunder, except as expressly set forth
in a Development Plan, to reverse engineer the Product, generate analogs of or
derivatives based on the Product, chemically analyze or chemically modify the
structure of the Product, or develop formulations of the Product.


 


6.6                               Exclusivity.


 


(a)                                  3SBio hereby covenants that during the
Term and for [***] thereafter, except for activities expressly
authorized under this Agreement, 3SBio and its Affiliates will not, and 3SBio
will [***] do not,
either directly or indirectly develop, manufacture, market, promote, import,
export, or sell anywhere in the world any [***] without AMAG’s prior written consent.


 






[***] INDICATES MATERIAL
THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED.
ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT
OF 1934, AS AMENDED.


 


26

















 


(b)                                  3SBio hereby further covenants that
during the Term and for [***] thereafter, except for activities expressly
authorized under this Agreement, 3SBio and its Affiliates will not, and 3SBio
will [***], either
directly or indirectly develop, manufacture, market, promote, import, export,
or sell anywhere in the world any Generic Version without AMAG’s prior written
consent.


 


(c)                                  Notwithstanding the foregoing Sections
6.6(a) and 6.6(b), 3SBio and its Affiliates shall be permitted to continue
to sell the product described in Exhibit F
(the “Existing Product”) until Regulatory
Approval is obtained for the Product for the Initial Indication in the Licensed
Territory, and shall thereafter immediately cease all activities with respect
to the Existing Product; provided
that [***].


 


(d)                                  In the event that this Agreement expires
for failure to extend its Term pursuant to Section 13.1 herein due to the
annual Net Sales of the Product in the Licensed Territory for the year
immediately preceding the renewal year not exceeding [***], the Parties acknowledge and agree that Section 6.6(a) shall
not apply and shall be void and have no force or effect.  In the event that this Agreement is
terminated pursuant to Section 13.2 herein due to uncured material breach
by AMAG of this Agreement (except for any deemed material breach of this
Agreement under Section 9.1 of the Supply Agreement) or willful breach by
AMAG of Section 5.4 of the Supply Agreement, the Parties acknowledge and
agree that Section 6.6(a) shall not apply and shall be void and have
no force or effect.


 


(e)                                  The Parties acknowledge and agree that
the covenants in this Section 6.6 are reasonable and appropriate in the
context of the licenses granted to 3SBio in this Article 6 and other terms
of this Agreement.  The Parties agree
that if this Section 6.6 is held to be invalid or unenforceable by any
arbitrator or court of competent jurisdiction, then the Parties shall revise
the covenants in this Section 6.6 in a manner that will render such
provision valid while maximizing the duration and geographic scope of such
covenants, consistent with the Parties’ original intent.


 


ARTICLE 7

MANUFACTURE AND SUPPLY


 


7.1                               General.  AMAG will supply, or cause to be supplied
through its contract manufacturers, Product in unlabeled finished form to 3SBio
for both Development and Commercialization purposes, subject to the terms of
the Supply Agreement described in Section 7.2.  3SBio shall be responsible, at its own
expense, for the final labeling and packaging of the finished form of the
Product in the Licensed Territory for both Development and Commercialization
purposes, and for seeking and maintaining all Regulatory Approvals associated
with all such activities.  AMAG shall
have the right, upon reasonable advance notice to 3SBio, to visit any
manufacturing, storage, or distribution facility of 3SBio or its Affiliates or


 






[***] INDICATES MATERIAL
THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED.
ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT
OF 1934, AS AMENDED.


 


27

















 


sublicensees during
regular business hours to review operations and assess compliance with
applicable Laws, and to discuss any related issues with 3SBio’s or its
Affiliates’ or sublicensees’ personnel.


 


7.2                               Supply Agreement.  Concurrently
with the execution of this Agreement, the Parties are entering into a
manufacturing and supply agreement (the “Supply Agreement”),
attached hereto as Exhibit E,
governing the Development and Commercialization supply to 3SBio of finished
Product by or on behalf of AMAG.


 


ARTICLE 8

FINANCIALS


 


8.1                               Development and Commercialization
Expenses.


 


(a)                                  Reconciliation Payments [***].  Within twenty
(20) days after the end of each calendar quarter for as long as the Parties are
conducting any Co-Developed Indication Phase III Clinical Trials, each Party
shall submit to the JSC a statement setting forth [***] it incurred in such calendar
quarter.  Within thirty (30) days after
receipt of such reports, the JSC shall notify the Parties whether a
reconciliation payment is due from one Party to the other, and if so, the
amount of such reconciliation payment (a “Reconciliation Notice”),
so that the Parties [***] for such calendar quarter.  The Party required to pay such reconciliation
payment shall submit such payment to the other Party or object to the
Reconciliation Notice in writing to the other Party and the JSC within thirty
(30) days after receiving notice from the JSC. 
In the event a Party chooses to pay the amounts set forth in any
Reconciliation Notice in accordance with the immediately preceding sentence,
the amount of [***] for the applicable quarter shall be deemed final and
unappealable, other than in connection with a formal audit as provided in Section 8.9.


 


(b)                                  No Other Payments. 
Except for [***], each Party shall bear all expenses it incurs under
this Agreement.  Without limiting the
generality of the foregoing, 3SBio shall solely bear all expenses it incurs for
all Development activities other than the Co-Developed Indication Phase III
Clinical Trials and for conducting all activities under the Marketing Plan.


 


8.2                               License Fee. 
No later than five (5) days after the Effective Date, 3SBio shall
pay to AMAG a license fee of One Million Dollars ($1,000,000) by wire transfer
of immediately available funds into a deposit account designated in writing by
AMAG.  Such license fee shall be
nonrefundable and non-creditable against any other payments due hereunder.  The Parties acknowledge and agree that the
license fee is not a payment or reimbursement for services provided by AMAG to
3SBio under this Agreement and that such fee is in consideration of the
licenses granted under Section 6.1 of this Agreement.


 






[***]
INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 


28

















 


8.3                               Development Milestone
Payments.  3SBio shall make milestone payments to
AMAG based on the achievement of certain milestone events in the Licensed
Territory for the Product as set forth in this Section 8.3.  3SBio shall pay to AMAG the amounts set forth
below within thirty (30) days after the achievement of the corresponding
milestone event.  For clarity, the first
milestone payment listed below [***]. 
Each such payment shall be made by wire transfer of immediately
available funds into a deposit account designated by AMAG.  Each such payment shall be nonrefundable and
non-creditable against any other payments due hereunder.  The Parties acknowledge and agree that the
milestone payments are not payments or reimbursements for services provided by
AMAG to 3SBio under this Agreement and that such fee is in consideration of the
licenses granted under Section 6.1 of this Agreement.


 


	
  Milestone Event

  	
   

  	
  Milestone Payment

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  



 


8.4                               Royalties.


 


(a)                                  Royalties. 
Subject to Sections 8.4(c), 8.4(e) and 8.9, 3SBio shall pay to AMAG
nonrefundable, non-creditable royalties based on the aggregate annual Net Sales
in the Licensed Territory of the Product for the Initial Indication and for all
Co-Developed Indications, as calculated by multiplying the applicable royalty
rates by the corresponding amount of incremental Net Sales in such calendar
year.


 


	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  



 


(b)                                  Royalty Term. 
Royalties due under Section 8.4(a) will commence on the First
Commercial Sale of the Product in the Licensed Territory and will be payable
for so long as 3SBio is Commercializing the Product under this Agreement.


 


(c)                                  Reduction of Royalty
Following Generic Entry.  Following commercial sale of a
Generic Version by a Third Party in the Licensed Territory after Regulatory
Approval


 






[***] INDICATES
MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.


 


29

















 


of the Product, the royalty rates
set forth in Section 8.4(a) shall be modified if, [***] 3SBio, in exercising Diligent Efforts to
Commercialize the Product, [***] (such event a “Generic
Entry Trigger”).  In the event
of a Generic Entry Trigger, the royalty rate set forth in Section 8.4(a) shall
automatically be reduced as follows:


 


	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  



 


In the event of [***] in the Licensed Territory of more than [***] as compared to the [***] immediately prior to such Third Party
sale, the Parties agree to mutually and in good faith reconsider the
continuation of this Agreement and their respective obligations hereunder;
provided, that neither Party shall be obligated to agree to any amendment to
this Agreement.  The determination
of a Generic Entry Trigger and [***] of the Product
shall be based upon the pricing information provided by 3SBio to AMAG pursuant
to Sections 5.1-5.4 of this Agreement. 
3SBio shall provide AMAG with all supporting records and documentation
reasonably requested by AMAG to support such determination and [***].


 


(d)                                  Royalty Payments and Reports. All amounts payable to AMAG pursuant to Section 8.4(a) shall
be paid within forty-five (45) days after the end of each calendar quarter with
respect to Net Sales in such calendar quarter. 
Payments made directly to AMAG shall be converted to Dollars (or some
other freely convertible currency upon approval by AMAG), made in Dollars, and
made by wire transfer of immediately available funds into a deposit account of
AMAG designated by AMAG from time to time. 
Payment of any such amounts shall be considered effected as of the date
on which AMAG’s account is credited with the applicable amount.  Each payment of royalties due to AMAG shall
be accompanied by a statement of the amount of gross sales of Product for the
Initial Indication and for each Co-Developed Indication in the Licensed
Territory during the applicable calendar quarter, an itemized calculation of
Net Sales in the Licensed Territory showing deductions provided for in the
definition of “Net Sales” during such calendar quarter, and a calculation of
the amount of royalty payment due on such sales for such calendar quarter.  3SBio shall require its permitted
sublicensees to account for their Net Sales and to provide such reports with
respect thereto as if such sales were made by 3SBio.


 


(e)                                  Third Party Royalties.  If it is necessary for 3SBio to enter into any
license, assignment or other agreement with any Third Party for the right to
Develop, use or Commercialize the Product in the Licensed Territory, 3SBio
shall obtain such agreement (with


 






[***] INDICATES MATERIAL
THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED.
ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT
OF 1934, AS AMENDED.


 


30

















 


the consent of AMAG) and
shall be responsible to the Third Party for all payments under such agreement
for the Licensed Territory (all such agreements, the “Third Party
License Agreements”).  3SBio
shall have [***],
provided that with respect to any Third Party License Agreement necessary for
Development, use or Commercialization of the Product in the Licensed Territory
in the Initial Indication, such [***].


 


8.5                               Taxes.


 


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


 


(b)                                  Payment of Tax.  A Party receiving a payment pursuant to this Article 8
shall pay any and all taxes levied on such payment.  If applicable Law requires that taxes be
deducted and withheld from a payment made pursuant to this Article 8, the
remitting Party shall (i) withhold those taxes from the payment; (ii) pay
the taxes to the proper taxing authority; and (iii) send evidence of the
obligation together with proof of payment to the other Party within sixty (60)
days following that payment.  If, as a
result of any change in the corporate status or location of 3SBio or its
Affiliates, or the permitted assignment of this Agreement by 3SBio, additional
withholding taxes become due on payments to AMAG that would not have been due
absent such change in corporate status or location or permitted assignment, and
AMAG is not able to claim a credit or reimbursement for such tax, in whole or
in part, then 3SBio shall deduct such taxes in accordance with this Section 8.5(b),
but shall, in addition to the sums otherwise payable under this Agreement, pay
to AMAG such further sum as shall ensure that, after deduction of such taxes,
the net amount received by AMAG equals the amount that AMAG would have received
had the non-creditable or non-reimbursable amount of such additional taxes not
been deducted.


 


(c)                                  Tax Residence
Certificate.  A Party (including any entity to which
this Agreement may be assigned, as permitted under Section 15.5) receiving
a payment pursuant to this Article 8 shall provide the remitting Party
appropriate certification from relevant revenue authorities that such Party is
a tax resident of that jurisdiction (a “Tax
Residence Certificate”), if such receiving Party wishes to claim the
benefits of an income tax treaty to which that jurisdiction is a party.  Upon the receipt thereof, any deduction and
withholding of taxes shall be made at the appropriate treaty tax rate.


 


(d)                                  Assessment.  Either Party may, at its own expense, protest any
assessment, proposed assessment, or other claim by any Governmental Authority
for any additional amount of taxes, interest or penalties or seek a refund of
such amounts paid if


 






[***] INDICATES MATERIAL
THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED.
ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT
OF 1934, AS AMENDED.


 


31

















 


permitted to do so by
applicable Law.  The Parties shall
cooperate with each other in any protest by providing records and such
additional information as may reasonably be necessary for a Party to pursue
such protest.


 


8.6                               Blocked Currency. 
In the event that 3SBio is prohibited or restricted from making payment
of any monies at a time when such monies are due and payable to AMAG hereunder
by any reason of a legal requirement within the Licensed Territory, 3SBio shall
promptly so advise AMAG in writing. 
3SBio shall, upon AMAG’s request, deposit any blocked funds to the
credit of AMAG in a separate interest-bearing account in a bank or other
depository in the Licensed Territory designated in writing by AMAG, or pay such
funds promptly to such person or entity as AMAG may designate in writing.  3SBio shall be jointly and severally liable
for any additional costs, or any reduction in value of local currency,
resulting from failure of 3SBio to comply with such instructions to make
payment.  The funds therein shall be
remitted to AMAG promptly upon the lifting of the prohibition or restriction
under such legal requirement.


 


8.7                               Foreign Exchange. 
The exchange rate at which Chinese renminbi (“RMB”)
shall be converted into Dollars, or some other freely convertible currency as
approved by AMAG, shall be the telegraphic transfer selling rate for Dollars or
such other approved foreign currency quoted by the People’s Bank of China (“PBOC”) at or about 10:00 a.m. on the earlier of the
due date or the date of remittance, provided that the date of remittance shall
not be later than the last permissible date for payment under this Agreement,
and provided further that the rate quoted by Bank of China shall be used should
the PBOC cease to quote such rate.  All
payments made by AMAG to 3SBio under this Agreement shall be made in RMB to a
bank account opened and maintained by 3SBio for this specific purpose.


 


8.8                               Late Payments. 
If a Party does not receive payment of any sum due to it on or before
the due date, simple interest shall thereafter accrue on the sum due to until
the date of payment at the per annum rate of two percent (2%) over the
then-current prime rate quoted by Citibank in New York City or the maximum rate
allowable by applicable Law, whichever is less. 
In addition to any other remedies AMAG may have, 3SBio shall be solely
responsible for any additional costs, or any reduction in value of local
currency in relation to Dollars, resulting from untimely payments during any
period after amounts payable to AMAG hereunder are due.


 


32
















 


8.9                               Records; Audits.


 


(a)                                  3SBio will maintain complete and accurate
records in sufficient detail to permit AMAG to confirm the accuracy of the
calculation of royalty payments and [***] under this Agreement.  Upon reasonable prior notice, such records
shall be available during regular business hours for a period of three (3) years
from the creation of individual records for examination at AMAG’s expense, and
not more often than once each calendar year, by an independent certified public
accountant selected by AMAG and reasonably acceptable to 3SBio, for the sole
purpose of verifying the accuracy of the financial reports furnished by 3SBio
pursuant to this Agreement.  Any such
auditor shall not disclose 3SBio’s Confidential Information, except to the
extent such disclosure is necessary to verify the accuracy of the financial
reports furnished by 3SBio or the amount of payments due by 3SBio under this
Agreement.  Any amounts shown to be owed
but unpaid shall be paid within thirty (30) days from the accountant’s report,
plus interest (as set forth in Section 8.8) from the original due
date.  Any amounts shown to be overpaid
shall be repaid by AMAG to 3SBio within thirty (30) days from the accountant’s
report.  AMAG shall bear the full cost of
such audit unless such audit discloses an underpayment of the amount actually
owed during the applicable calendar year of more than five percent (5%), in
which case 3SBio shall bear the full cost of such audit.


 


(b)                                  AMAG will maintain complete and accurate
records in sufficient detail to permit 3SBio to confirm the accuracy of the
calculation of [***] under this Agreement. 
Upon reasonable prior notice, such records shall be available during
regular business hours for a period of three (3) years from the creation
of individual records for examination at 3SBio’s expense, and not more often
than once each calendar year, by an independent certified public accountant
selected by 3SBio and reasonably acceptable to AMAG, for the sole purpose of
verifying the accuracy of the financial reports furnished by AMAG pursuant to
this Agreement.  Any such auditor shall
not disclose AMAG’s Confidential Information, except to the extent such
disclosure is necessary to verify the accuracy of the financial reports
furnished by AMAG or the amount of Shared Costs due by AMAG under this
Agreement.  Any amounts shown to be owed
but unpaid shall be paid within thirty (30) days from the accountant’s report,
plus interest (as set forth in Section 8.8) from the original due
date.  Any amounts shown to be overpaid
shall be repaid by 3SBio to AMAG within thirty (30) days from the accountant’s
report. 3SBio shall bear the full cost of such audit unless such audit
discloses an overpayment of such costs by 3SBio during the applicable calendar
year of more than five percent (5%), in which case AMAG shall bear the full
cost of such audit.


 


ARTICLE 9

INTELLECTUAL PROPERTY MATTERS


 


9.1                               Ownership of Inventions;
Assignment.  Subject to the license granted in Section 6.1,
AMAG shall own all right, title, and interest in and to any inventions made
solely or jointly


 






[***] INDICATES MATERIAL
THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED.
ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT
OF 1934, AS AMENDED.


 


33

















 


by either Party’s
employees, agents, or independent contractors in the course of conducting its
activities under this Agreement, in each case to the extent related to the
Product, together with all intellectual property rights therein, including
without limitation any rights to applications or other protections for any of
the foregoing (“Inventions”).  Inventions shall be included in the AMAG
Know-How.  3SBio agrees to assign and
hereby assigns and transfers to AMAG all of its right, title and interest in
and to the Inventions and agrees to take, and to cause its employees, agents,
and consultants to take, all further acts reasonably required to evidence such
assignment and transfer to AMAG, at AMAG’s reasonable expense.  3SBio hereby appoints AMAG as its
attorney-in-fact to sign such documents as AMAG deems necessary for AMAG to
obtain ownership and to apply for, secure, and maintain patent or other
proprietary protection of such Inventions if AMAG is unable, after reasonable
inquiry, to obtain 3SBio’s (or its employee’s or agent’s) signature on such a
document.  3SBio hereby waives, on behalf
of itself, its parent, subsidiaries, Affiliates and partners as well as all of
its employees and independent contractors, any rights of first refusal it, he,
or she may have with respect to any contemplated technology transfer, in whole
or in part, of the Inventions or any related Patent, Patent application,
copyright or copyright application related thereto as well as any right
accorded to it, him, or her, by statute or otherwise, to use any Invention or
any Patent or copyright related thereto.


 


9.2                               Disclosure of
Inventions.  3SBio shall promptly disclose to AMAG all
Inventions and any invention disclosures, or other similar documents, submitted
to it by its employees, agents or independent contractors describing inventions
that may be Inventions, and all Information relating to such Inventions.


 


9.3                               Collaboration Patents.  AMAG shall have the sole right to
prepare, file, prosecute and maintain any Patents claiming or covering any
Invention (the “Collaboration Patents”).  AMAG shall bear all costs and expenses it
incurs with respect to the filing, prosecution, and maintenance of the
Collaboration Patents, except as otherwise provided below.  If AMAG determines that it is no longer
interested in supporting the continued prosecution or maintenance of a particular
Collaboration Patent in the Licensed Territory, AMAG shall, if requested in
writing by 3SBio, assign its ownership interest in such Collaboration Patent in
the Licensed Territory to 3SBio for no additional consideration, in which case
3SBio shall be solely responsible for the prosecution and maintenance of such
Collaboration Patent, at its sole expense.  
3SBio shall provide AMAG all reasonable assistance and cooperation in
the Patent prosecution efforts described in this Section 9.3, including
providing any necessary powers of attorney and executing any other required
documents or instruments for such prosecution.


 


9.4                               Infringement of Collaboration
Patents by Third Parties.


 


(a)                                  Notification.  3SBio shall promptly notify AMAG
in writing of any existing or threatened infringement of the Collaboration
Patents of which it becomes aware, and shall provide evidence in its possession
demonstrating such infringement.


 


(b)                                  Infringement of Collaboration
Patents in the Licensed Territory.


 


(i)                                    If a Third Party infringes any
Collaboration Patent in the Licensed Territory by making, using, importing,
offering for sale or selling the Product (such infringement, a “Product Infringement”), 3SBio shall so
notify AMAG as provided in Section 9.4(a),


 


34

















 


which such notice shall
include all Information available to 3SBio regarding such alleged infringement,
and AMAG shall have the right, but not the obligation, to bring an appropriate
suit or other action against any person or entity engaged in such Product
Infringement in the Licensed Territory, subject to Section 9.4(b)(ii) below.  AMAG shall have a period of one hundred
twenty (120) days after delivery to it of such notice and Information, to elect
to so enforce such Collaboration Patent. 
In the event it does not so elect, it shall so notify 3SBio in writing,
and 3SBio shall have the right to commence a suit or take action to enforce the
applicable Collaboration Patent against such Third Party perpetrating such
Product Infringement, unless AMAG
has a reasonable business basis to conclude that the enforcement of such
Collaboration Patent against such Product Infringement would have an adverse
impact on the Commercialization of the Product in the United States.  In the event AMAG has such a reasonable
business basis, it shall provide 3SBio such basis in writing within such one
hundred twenty (120) day period, in which case 3SBio shall not have such
enforcement right, subject to 3SBio’s right to challenge AMAG’s reasonable
business basis pursuant to Section 14.2 of this Agreement.  Each Party shall provide to the Party
enforcing any such rights under this Section 9.4(b)(i) reasonable
assistance in such enforcement, at such enforcing Party’s request and expense,
including joining such action as a party plaintiff if required by applicable
Law to pursue such action.  The enforcing
Party shall keep the other Party regularly informed of the status and progress
of such enforcement efforts, and shall reasonably consider the other Party’s
comments on any such efforts.  Each Party
shall bear all of its own internal and external costs incurred in connection
with its activities under this Section 9.4(b)(i).


 


(ii)                                The Party not bringing an action with
respect to Product Infringement in the Licensed Territory under this Section 9.4(b) shall
be entitled to separate representation in such matter by counsel of its own
choice and at its own expense, but such Party shall at all times cooperate
fully with the Party bringing such action.


 


(c)                                  Infringement of Collaboration
Patents in the AMAG Territory.  For any and
all infringements of Collaboration Patents anywhere in the AMAG Territory, AMAG
shall have the sole and exclusive right to bring an appropriate suit or other
action against any person or entity engaged in such infringement, in its sole
discretion, and as between the Parties shall bear all related expenses and
retain all related recoveries.


 


(d)                                  Settlement.  3SBio shall not settle any claim,
suit or action that it brings under this Section 9.4 involving
Collaboration Patents in any manner that would negatively affect the
Collaboration Patents in the AMAG Territory or that would limit or restrict the
ability of AMAG or its Affiliates or sublicensees to manufacture, Develop or
Commercialize the Product anywhere in the AMAG Territory, without the prior
written consent of AMAG.  AMAG shall not
settle any claim, suit or action that it brings under this Section 9.4
involving Collaboration Patents in any manner that would negatively affect the
Collaboration Patents in the Licensed Territory or that would limit, restrict
or otherwise negatively affect the ability of 3SBio or its Affiliates or
sublicensees to Develop or Commercialize the Product in the Licensed Territory,
without the prior written consent of 3SBio.


 


(e)                                  Allocation of Proceeds.  If either Party recovers monetary
damages from any Third Party in a suit or action brought under Section 9.4(b),
such recovery shall be allocated


 


35

















 


first to the
reimbursement of any expenses incurred by the Parties in such litigation
(including, for this purpose, a reasonable allocation of expenses of internal
counsel), and any remaining amounts shall be shared equally by the Parties.


 


9.5                               Infringement or Misappropriation
of AMAG Know-How.  For any and all infringements or
misappropriations of the AMAG Know-How anywhere in the Licensed Territory or
the AMAG Territory, AMAG shall have the sole and exclusive right to bring an
appropriate suit or other action against any person or entity engaged in such
infringement or misappropriation and, as between the Parties, shall bear all
related expenses and retain all related recoveries; provided that (i) AMAG shall use Diligent Efforts to
take action to enforce the AMAG Know-How against any Third Party infringing or
misappropriating such AMAG Know-How to the extent it adversely affects or may
reasonably be expected to adversely affect the Development or Commercialization
of the Product in the Licensed Territory and (ii) AMAG shall not settle
any claim, suit or action that it brings under this Section 9.5 involving
AMAG Know-How in any manner that would adversely affect the AMAG Know-How or
that would limit or restrict the ability of 3SBio or its Affiliates or
sublicensees to Develop or Commercialize the Product in the Licensed Territory
in accordance with the terms of this Agreement, without the prior written
consent of 3SBio.


 


9.6                               Infringement of Third Party
Rights in the Licensed Territory.


 


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


 


(b)                                  Defense. 
AMAG shall have the first right, but not the obligation, to defend any
such claim, with AMAG’s costs to conduct such defense being at AMAG’s
expense.  If AMAG does not commence
actions to defend such claim within sixty (60) days after it receives notice
thereof (or within sixty (60) days after it should have given notice thereof to
3SBio as required by Section 9.6(a)), or such shorter period as may be
required to allow 3SBio timely to respond to an action that has been filed
against it, then 3SBio shall have the right, but not the obligation, to control
the defense of such claim by counsel of its choice, at 3SBio’s expense. The
non-defending Party shall reasonably cooperate with the Party conducting the
defense of the claim, including, if required to conduct such defense,
furnishing a power of attorney.


 


(c)                                  Settlement. 
Neither Party shall enter into any settlement of any claim described in
this Section 9.6 that affects the other Party’s rights or interests
without such other Party’s written consent, which consent shall not be
unreasonably withheld or delayed.  AMAG
shall have the right to decline to defend or to tender defense of any such
claim to 3SBio upon reasonable notice, including without limitation if 3SBio
fails to agree to a settlement that AMAG proposes.


 


36

















 


9.7                               Patent Marking. 
3SBio (or its Affiliate, permitted sublicensee or distributor) shall
mark Products marketed and sold by 3SBio (or its Affiliate, permitted
sublicensee or distributor) hereunder with appropriate patent numbers or
indicia at AMAG’s request to the extent permitted by applicable Law, if such
markings or such notices affect recoveries of damages or equitable remedies
available with respect to infringements of patents.


 


9.8                               Infringement of Trademarks by
Third Parties.  With respect to any AMAG House Marks, AMAG
Product Marks or New Product Marks within the Licensed Territory, each Party
shall notify the JSC promptly upon learning of any actual, alleged or
threatened infringement of any trademark or of any unfair trade practices,
trade dress imitation, passing off of counterfeit goods, or like offenses,
against such trademark (hereinafter “TM
Infringement”).  Upon learning
of such TM Infringement, the JSC shall confer as to the best response to such
TM Infringement.  In the absence of other
agreement between the Parties, the Party whose trademark is the subject of such
apparent TM Infringement shall have the sole right, in its own discretion and
at its own expense, to bring an action to address such TM Infringement, in which
case such Party shall retain any damages recovered from the Third Party.  If relevant, if the trademark at issue is one
as to which 3SBio was granted a license by AMAG, 3SBio shall fully cooperate
with AMAG in any such litigation, at the expense of AMAG. In the event that
AMAG does not proceed with the litigation, 3SBio shall be entitled to conduct
such litigation in its own name and to receive any damages resulting from such
litigation.


 


9.9                               Patent Oppositions and Other
Proceedings.


 


(a)                                  Third-Party Patent Rights. 
If either Party desires to bring an opposition, action for declaratory
judgment, nullity action, interference, declaration for non-infringement,
reexamination or other attack upon the validity, title or enforceability of a
Patent owned or controlled by a Third Party that may cover the Product, or the
manufacture, use, sale, offer for sale or importation of the Product (except
insofar as such action is a counterclaim to or defense of, or accompanies a
defense of, a Third Party’s claim or assertion of infringement under Section 9.6,
in which case the provisions of Section 9.6 shall govern), such Party
shall so notify the other Party, and the Parties shall promptly confer to
determine whether to bring such action or the manner in which to settle such
action.  AMAG shall have the exclusive
right, but not the obligation, to bring at its own expense and in its sole
control such action in the AMAG Territory or the Licensed Territory.  If AMAG does not bring such an action in the
Licensed Territory, within ninety (90) days of notification thereof pursuant to
this Section 9.9(a) (or earlier, if required by the nature of the
proceeding), then 3SBio shall have the right, but not the obligation, to bring,
at 3SBio’s sole expense, such action. 
The Party not bringing an action under this Section 9.9(a) shall
be entitled to separate representation in such proceeding by counsel of its own
choice and at its own expense, and shall cooperate fully with the Party
bringing such action.  Any awards or
amounts received in bringing any such action shall be first allocated to
reimburse the Parties’ expenses in such action, and any remaining amounts shall
be retained by the Party bringing such action.


 


(b)                                  Parties’ Patent Rights. 
If any Collaboration Patent becomes the subject of any proceeding within
the Licensed Territory commenced by a Third Party in connection with an
opposition, reexamination request, action for declaratory judgment, nullity
action, interference


 


37

















 


or other attack upon the
validity, title or enforceability thereof (except insofar as such action is a
counterclaim to or defense of, or accompanies a defense of, an action for
infringement against a Third Party under Section 9.4, in which case the
provisions of Section 9.4 shall govern), then AMAG shall control such
defense at its sole cost.  AMAG shall
permit 3SBio to participate in the proceeding to the extent permissible under
applicable Law, and to be represented by its own counsel in such proceeding, at
3SBio’s expense.  If AMAG decides that it
does not wish to defend against such action, then 3SBio shall have a backup
right to assume defense of such Third-Party action at its own expense.  Any awards or amounts received in defending
any such Third-Party action shall be allocated between the Parties as provided
in Section 9.4(e).


 


ARTICLE 10



REPRESENTATIONS AND WARRANTIES


 


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


 


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


 


(b)                                  Authority and Binding Agreement. 
As of the Effective Date, (i) it has the corporate power and
authority and the legal right to enter into this Agreement and perform its
obligations hereunder; (ii) it has taken all necessary corporate action on
its part required to authorize the execution and delivery of this Agreement and
the performance of its obligations hereunder; and (iii) this Agreement has
been duly executed and delivered on behalf of such Party and constitutes a
legal, valid, and binding obligation of such Party that is enforceable against
it in accordance with its terms.


 


(c)                                  No Conflict. 
It is not a party to any agreement that would materially prevent it from
granting the rights granted to the other Party under this Agreement or
performing its obligations under this Agreement.


 


(d)                                  No Debarment. 
In the course of the Development of the Product, such Party shall not
use, during the term of this Agreement, any employee or consultant who has been
debarred by any Regulatory Authority, or, to the best of such Party’s knowledge,
is the subject of debarment proceedings by a Regulatory Authority.


 


10.2                        Additional
Representations and Warranties of AMAG.  AMAG hereby further represents and
warrants to 3SBio as of the Effective Date as follows:


 


(a)                                  AMAG is the sole and
exclusive owner of, or has the exclusive right to license the AMAG Know-How as
to the Product in the Initial Indication for the Licensed Territory.


 


38

















 


(b)                                  No Claims are pending
or, to AMAG’s or its Affiliates’ knowledge, threatened against AMAG that (i) allege
that the Product or AMAG Know-How in any respect infringes or misappropriates
any Third Party’s intellectual property rights as applicable to the Licensed
Territory, or (ii) challenge AMAG’s ownership of, or the enforceability or
validity of the AMAG Know-How related to the Product in the Licensed Territory.


 


(c)                                  To the best of AMAG’s
and its Affiliates’ knowledge as of the Effective Date, the Product and AMAG
Know-How do not and will not infringe, constitute a misappropriation or
impairment of or otherwise cause damage to or interfere with any patent,
copyright, trademark, or design right of any other Person in the Licensed
Territory.


 


(d)                                  AMAG has used
reasonable measures to enforce non-disclosure and confidentiality policies and
has obtained agreements from employees, consultants and others relating to such
matters to protect its rights in and to the AMAG Know-How.


 


(e)                                  Neither AMAG nor its Affiliates have
granted to any Third Party any rights or licenses or have otherwise taken any
action that conflicts with or prevents the grant of the rights and licenses
granted to 3SBio under this Agreement.


 


For clarity, all representations and warranties in
this Section 10.2 with respect to the Product are for the Product as in
existence as of the Effective Date.


 


10.3                        Covenant. 
Each Party shall use reasonable measures
to enforce non-disclosure and confidentiality policies and will obtain
agreements from employees, consultants and others relating to such matters to
protect its rights in and to the AMAG Know-How.


 


10.4                        Disclaimer.   3SBio understands that the Product is the
subject of ongoing clinical research and development and that AMAG cannot
assure the safety or usefulness of the Product. 
In addition, AMAG makes no warranties except as set forth in this Article 10
concerning the AMAG Know-How.


 


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


 


ARTICLE 11

INDEMNIFICATION


 


11.1                        Indemnification by
AMAG.  AMAG shall defend, indemnify, and hold 3SBio and 3SBio’s
officers, directors, employees, and agents (the “3SBio Indemnitees”) harmless from and against any and all
Third Party claims, suits, proceedings, damages, expenses (including court
costs and reasonable attorneys’ fees and expenses), and recoveries
(collectively,


 


39

















 


“Claims”)  to
the extent that such Claims arise out of, are based on, or result from (a) the
Development, Commercialization, storage, handling, or use of Products by AMAG
or its Affiliates, licensees (other than 3SBio or its Affiliates) or agents
under this Agreement, including Claims based on injury, harm or death to a
patient based in strict products liability allegedly due and owing as a result
of the defective design of the Product by or on behalf of AMAG; (b) a
breach of any of AMAG’s or its Affiliates’ representations, warranties, and
obligations under this Agreement; or (c) the
willful misconduct or reckless or negligent acts of AMAG, its Affiliates, or
the officers, directors, employees, or agents of AMAG or its Affiliates.  The foregoing indemnity obligation shall not
apply if the 3SBio Indemnitees fail to comply with the indemnification
procedures set forth in Section 11.3, or to the extent that any Claim
arises from, is based on, or results from any activity for which 3SBio is
obligated to indemnify the AMAG Indemnitees under Section 11.2.  For clarity, AMAG shall in no event be
obligated under this Section 11.1 to indemnify a 3SBio Indemnitee to the
extent of any Claim that arises out of or relates to the Manufacture of the
Product by or on behalf of AMAG (it being understood that each Party’s rights
and remedies in respect of such Claims are set forth in Section 7 of the
Supply Agreement).


 


11.2                        Indemnification by
3SBio.  3SBio shall defend, indemnify, and hold AMAG and AMAG’s
officers, directors, employees, and agents (the “AMAG Indemnitees”) harmless from and against any and all
Claims to the extent that such Claims arise out of, are based on, or result
from (a) the Development, Commercialization, storage, handling, labeling,
or use of Products by 3SBio or its Affiliates, sublicensees, distributors, or
agents, including Claims based on injury, harm or death to a patient based in
strict products liability allegedly due and owing as a result of defective
warnings with respect to the Product by or on behalf of 3SBio; (b) a
breach of any of 3SBio’s or its Affiliates’ representations, warranties, and
obligations under this Agreement; or (c) the willful misconduct or
reckless or negligent acts of 3SBio, its Affiliates, or the officers,
directors, employees, or agents of 3SBio or its Affiliates.  The foregoing indemnity obligation shall not
apply if the AMAG Indemnitees fail to comply with the indemnification
procedures set forth in Section 11.3, or to the extent that any Claim
arises from, is based on, or results from any activity for which AMAG is
obligated to indemnify the 3SBio Indemnitees under Section 11.1.


 


11.3                        Indemnification
Procedures.  The Party claiming indemnity under this Article 11
(the “Indemnified Party”) shall
give written notice to the Party from whom indemnity is being sought (the “Indemnifying Party”) promptly after
learning of such Claim.  The Indemnified
Party shall provide the Indemnifying Party with reasonable assistance, at the
Indemnifying Party’s expense, in connection with the defense of the Claim for
which indemnity is being sought.  The
Indemnified Party may participate in and monitor such defense with counsel of
its own choosing at its sole expense; provided, that
the Indemnifying Party shall have the right to assume and conduct the defense
of the Claim with counsel of its choice. 
The Indemnifying Party shall not settle any Claim without the prior
written consent of the Indemnified Party, not to be unreasonably withheld,
unless the settlement involves only the payment of money.  So long as the Indemnifying Party is actively
defending the Claim in good faith, the Indemnified Party shall not settle any
such Claim without the prior written consent of the Indemnifying Party.  If the Indemnifying Party does not assume and
conduct the defense of the Claim as provided above, (a) the Indemnified
Party may defend against, and consent to the entry of any judgment or enter
into any settlement with respect to the Claim in any manner the


 


40

















 


Indemnified Party may
deem reasonably appropriate (and the Indemnified Party need not consult with,
or obtain any consent from, the Indemnifying Party in connection therewith),
and (b) the Indemnifying Party will remain responsible to indemnify the
Indemnified Party as provided in this Article 11.


 


11.4                        Limitation of
Liability.  NEITHER PARTY SHALL BE LIABLE TO THE
OTHER FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES
ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY
NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. 
NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 11.4 IS
INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR
OBLIGATIONS OF ANY PARTY UNDER SECTION 11.1 OR 11.2, OR DAMAGES AVAILABLE
FOR A PARTY’S BREACH OF SECTION 6.4 OR 6.6 OR CONFIDENTIALITY OBLIGATIONS
IN ARTICLE 12.


 


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


 


ARTICLE 12

CONFIDENTIALITY


 


12.1                        Confidentiality.  Except to the extent expressly authorized by this
Agreement or otherwise agreed in writing by the Parties, each Party agrees
that, for the Term and for [***] years thereafter, it shall keep confidential and
shall not publish or otherwise disclose and shall not use for any purpose other
than as provided for in this Agreement any Confidential Information furnished
to it by the other Party pursuant to this Agreement; provided,
that such confidentiality and non-use obligations will continue indefinitely
with respect to any CMC information.  The
foregoing obligations of confidentiality and non-use will not apply to any
portion of such information or materials that the receiving Party can
demonstrate by competent written proof:


 


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


 






[***] INDICATES MATERIAL
THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED.
ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT
OF 1934, AS AMENDED.


 


41
















 


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


 


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


 


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


 


(e)                                  was independently discovered or developed
by the receiving Party or its Affiliate without the aid, application, or use of
Confidential Information; provided, that
this exception shall not apply to information or materials consisting of data
and results generated or resulting from Development activities, which
information and materials shall be deemed Confidential Information of AMAG
regardless of whether such information and materials were independently
discovered or developed by 3SBio or any of its Affiliates.


 


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


 


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


 


(b)                                  prosecuting or defending litigation;


 


(c)                                  complying with applicable Laws;


 


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


 


(e)                                  disclosure of the material financial
terms of this Agreement to any bona fide potential investor, investment banker,
acquiror, merger partner, licensees, sublicensees or other potential financial
partner; provided, that in connection with such
disclosure, the disclosing Party shall use all reasonable efforts to inform
each recipient of the confidential nature of such Confidential Information and
cause each recipient of such Confidential Information to treat such
Confidential Information as confidential.


 


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


 


42

















 


Parties agree to take all reasonable action to avoid
disclosure of Confidential Information hereunder.


 


12.3                        Publicity; Terms of Agreement.


 


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


 


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


 


(c)                                  The Parties acknowledge that they each
may be obligated to file a copy of this Agreement with the U.S. Securities and
Exchange Commission (the “SEC”).  Each Party shall be entitled to make such a
required filing; provided, that it requests
confidential treatment of certain commercial terms and sensitive technical
terms hereof to the extent such confidential treatment is reasonably
available.  In the event of any such
filing, the Parties will coordinate their requests for confidential treatment
of certain commercial terms and sensitive terms of the Agreement to the extent
consistent with the legal requirements governing redaction of information from
material agreements that must be publicly filed and the Parties have agreed, as
of the Effective Date, on the redacted form of this Agreement and the Supply
Agreement to be submitted to the SEC. 
The Parties recognize that U.S. laws and SEC policies and regulations to
which AMAG and 3SBio are and may become subject may require them to publicly
disclose certain terms of this Agreement that one Party may prefer not be
disclosed, and that each Party is nonetheless entitled hereunder to make such
required disclosures.


 


12.4                        Pro Forma Agreement. 
The Parties acknowledge that either AMAG or 3SBio may be obligated to
file a copy of certain terms of this Agreement with Governmental Authorities in
the Licensed Territory for registration or approval purposes (e.g.,
registration of any trademark license with the Trademark Office or approval of
overseas remittances by the State Administration of Foreign Exchange).  Each Party agrees to execute for each such
purpose


 


43

















 


a tailored short-form
agreement that incorporates only those provisions required to be disclosed to
the relevant Governmental Authority (a “Pro Forma Agreement”)
and to timely file (with notice to the other Party) any such Pro Forma
Agreement required by the applicable Governmental Authority in the Licensed
Territory.  The terms of any Pro Forma
Agreement shall be Confidential Information of the Parties; provided that a
Party shall be entitled to file such Pro Forma Agreement with a Governmental
Authority solely to the extent required by Applicable Law.  A Party seeking to file a Pro Forma Agreement
will give reasonable advance notice to the other Party of such disclosure (and
such other Party shall assist in the preparation of the Pro Forma Agreement)
and use best efforts to secure confidential treatment of such Pro Forma
Agreement to the extent available under Applicable Law.


 


12.5                        Publications. 
3SBio shall not publish peer reviewed manuscripts, or give other forms
of public disclosure such as abstracts and presentations, of results of studies
carried out under this Agreement without the opportunity for prior review by
AMAG.  3SBio shall provide AMAG the
opportunity to review and comment on any proposed manuscripts or presentations
which relate to the Product at least thirty (30) days prior to their intended
submission for publication or presentation. 
3SBio shall consider the comments of AMAG and shall remove any and all
of AMAG’s Confidential Information at AMAG’s request.  3SBio shall provide AMAG a copy of the
manuscript at the time of the submission. 
3SBio shall not have the right to publish or present AMAG’s Confidential
Information without AMAG’s prior written consent, except as expressly permitted
in this Agreement.


 


ARTICLE 13

TERM AND TERMINATION


 


13.1                        Term. 
This Agreement shall become effective on the Effective Date and shall have
an initial term of thirteen (13) years, unless earlier terminated pursuant to
this Article 13.  Thereafter, the
Term shall automatically be extended for successive two (2) year periods, provided that the annual Net Sales of the
Product in the Licensed Territory for the year immediately preceding the
renewal year exceed [***].


 


13.2                        Termination for Material Breach.  Either Party shall have the right, but not the
obligation, to terminate this Agreement if the other Party, after receiving
written notice from such Party of a material breach under this Agreement, fails
to cure such material breach within ninety (90) days from the date of such
notice (or within twenty (20) days notice in the event such breach is solely
based upon the breaching Party’s failure to pay any amounts due
hereunder).  For the avoidance of doubt,
an uncured material breach of the Supply Agreement following notice by the
non-breaching Party and the applicable cure period shall be considered a material
breach of this Agreement.  Notwithstanding
the foregoing, no cure period shall apply with respect to termination due to
material breach of Article 12; in such case, the non-breaching Party 


 






[***] INDICATES MATERIAL
THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED.
ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT
OF 1934, AS AMENDED.


 


44

















 


shall have the right, but not the obligation, to terminate this
Agreement immediately upon written notice to the breaching Party.


 


13.3                        Termination for Failure to
Receive Regulatory Approval.  AMAG shall
have the right, but not the obligation, to terminate this Agreement if the Product
does not receive Regulatory Approval in the Licensed Territory within [***] after the Effective Date.


 


13.4                        Termination for Product Price
Increases.  3SBio shall have the right, but not the
obligation, to terminate this Agreement upon thirty (30) days written notice to
AMAG pursuant to Section 4.1(b) of the Supply Agreement.


 


13.5                        Effect of Expiration or
Termination of the Agreement. Upon any expiration or early
termination of this Agreement, the following shall apply:


 


(a)                                  Intellectual Property.  AMAG’s
license grants to 3SBio pursuant to Sections 6.1 and 6.2 shall terminate as of
the effective date of such termination or expiration.


 


(b)                                  Regulatory Materials. 
To the extent permitted by applicable Law, 3SBio shall transfer and
assign to AMAG all Regulatory Materials, including without limitation
Regulatory Approvals for the Product, in the Licensed Territory that are held
by or on behalf of 3SBio or its Affiliates.


 


(c)                                  Transition Assistance. 
3SBio shall provide such assistance, at no cost to AMAG, as may be
reasonably necessary to transfer and/or transition over a reasonable period of
time to AMAG all other technology or know-how, or then-existing commercial
arrangements, that is, or are, held by or on behalf of 3SBio or its Affiliates
and necessary or useful for AMAG to commence or continue Developing or
Commercializing the Product worldwide, to the extent 3SBio is then performing
or having performed such activities, including without limitation transferring,
upon request of AMAG, any agreements or arrangements with Third-Party vendors
to sell the Product in the Licensed Territory.


 


(d)                                  Assignment and License of
Intellectual Property Upon Termination and Expiration.


 


(i)                                    Effective upon any expiration or
termination of this Agreement, 3SBio shall assign to AMAG all of 3SBio’s rights
and interest in the New Product Marks (including any goodwill therewith) and
any variation thereof throughout the world, including any registrations and
design patents for the foregoing and Internet domain name registrations for
such trademarks and slogans.


 


(ii)                                Upon any expiration or termination other
than termination by 3SBio pursuant to Section 13.2 for AMAG’s uncured
material breach of this Agreement, to the


 






[***] INDICATES MATERIAL
THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED.
ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT
OF 1934, AS AMENDED.


 


45

















 


extent a license to any
3SBio Controlled intellectual property is necessary or useful for the continued
Development or Commercialization of the Product in the Licensed Territory as
conducted or contemplated to be conducted by 3SBio as of the effective date of
such termination, 3SBio hereby grants and shall grant to AMAG a perpetual,
royalty-free license, with the right to grant multiple tiers of sublicenses,
under such intellectual property solely to develop, make, have made, use, sell,
offer for sale, have sold and import the Product in the Licensed Territory,
which license shall be effective as of the date of such expiration or
termination, and shall be exclusive solely as to intellectual property that is
solely related to the Product and non-exclusive as to any intellectual property
that is not solely related to the Product.


 


(e)                                  License of Intellectual Property
Upon Termination for AMAG Material Breach.  In addition
to the rights described above in this Section 13.5, but not including Section 13.5(d)(ii),
if 3SBio terminates this Agreement pursuant to Section 13.2 for AMAG’s
uncured material breach of this Agreement, then:


 


(i)                                     to the extent a license to any 3SBio
Controlled intellectual property is necessary for the continued Development or
Commercialization of the Product in the Licensed Territory as conducted by
3SBio as of the effective date of such termination, 3SBio hereby grants to AMAG
a royalty-bearing license, with the right to grant multiple tiers of
sublicenses, under such intellectual property solely to develop, make, have
made, use, sell, offer for sale, have sold and import the Product in the Licensed
Territory, which
license shall be exclusive solely as to intellectual property that is solely
related to the Product and non-exclusive as to any intellectual property that
is not solely related to the Product and shall be effective as of the date of
such expiration or termination.  The
Parties shall use reasonable efforts to agree to the above-described royalty
rate within the thirty (30) day period following such termination, and if the
Parties are unable to so agree, then AMAG may invoke the provisions of Section 14.3
for a final and binding determination of the royalty rate by the Panel (as
defined in Section 14.3).


 


(ii)           to the extent a license to any 3SBio
Controlled intellectual property is only useful (and not necessary) for the
continued Development or Commercialization of the Product in the Licensed
Territory as conducted by 3SBio as of the effective date of such termination,
3SBio may, in its sole discretion, grant to AMAG a royalty-bearing license,
with the right to grant multiple tiers of sublicenses, under such intellectual
property solely to develop, make, have made, use, sell, offer for sale, have
sold and import the Product in the Licensed Territory, which license shall be exclusive solely
as to intellectual property that is solely related to the Product and
non-exclusive as to any intellectual property that is not solely related to the
Product and shall be effective as of the date of such expiration or
termination.  For clarity, in the event
this Agreement is terminated by 3SBio pursuant to Section 13.2 for AMAG’s
uncured material breach of this Agreement, 3SBio shall not be obligated to
license any 3SBio Controlled intellectual property under the terms of this Section 13.5(e)(ii) to
the extent that such intellectual property is only useful (but not necessary)
for the continued Development or Commercialization of the Product in the
Licensed Territory as conducted or contemplated to be conducted by 3SBio as of
the effective date of such termination.


 


(f)                                    Remaining Inventories. 
AMAG shall have the right to purchase from 3SBio all of the inventory
held by 3SBio or its Affiliates as of the effective date of termination or


 


46

















 


expiration of this
Agreement at a price equal to 3SBio’s actual cost to acquire such
inventory.  AMAG shall notify 3SBio
within thirty (30) days after the date of termination or expiration of the
Agreement whether AMAG elects to exercise such right.  If AMAG does not exercise such right, then
3SBio shall have the right to sell in the Licensed Territory any such remaining
inventory over a period of no greater than six (6) months after the
effective date of termination or expiration of this Agreement.


 


13.6                        Survival. 
The following provisions shall survive any expiration or termination of
this Agreement for the period of time specified: Sections 4.9, 5.7(d), 6.6,
8.5, 8.6, 8.9, 10.4, 10.5, 13.5 and 13.6 and Articles 9, 11, 12, 14 and 15.


 


ARTICLE 14



DISPUTE RESOLUTION


 


14.1                        English Language; Governing Law. This Agreement was prepared in the
English language, which language shall govern the interpretation of, and any
dispute regarding, the terms of this Agreement. 
This Agreement and all disputes arising out of or related to this
Agreement or any breach hereof shall be governed by and construed under the
laws of the State of New York, without giving effect to any choice of law
principles that would require the application of the laws of a different state.


 


14.2                        Disputes. 
The Parties recognize that disputes as to certain matters may from time
to time arise during the Term that relate to either Party’s rights and/or
obligations hereunder.  It is the
objective of the Parties to establish procedures to facilitate the resolution
of disputes arising under this Agreement in an expedient manner by mutual
cooperation and without resort to litigation. 
To accomplish this objective, the Parties agree to follow the procedures
set forth in this Article 14 if and when a dispute arises under this
Agreement.


 


(a)                                  Referred From JSC.  With respect to disputes arising from the JSC pursuant
to Section 2.2(e), if the JSC is unable to resolve any matter within ten (10) days
after taking such matter up for decision, either Party may, by written notice
to the other Party, have such dispute referred to the Chief Executive Officer
of each Party, or their designees, for attempted resolution by good faith
negotiations within thirty (30) days after such notice is received.  If the Chief Executive Officers of the
Parties, or their designees, are not able to resolve such dispute within such
thirty (30) day period, either Party may at any time thereafter invoke the
provisions of Exhibit G.


 


(b)                                  Arising Between the
Parties.  With respect to all disputes arising between the
Parties and not from the JSC, including, without limitation, any alleged
failure to perform, or breach of this Agreement, or any issue relating to the
interpretation or application of this Agreement, if the Parties are unable to
resolve such dispute within thirty (30) days after such dispute is first
identified by either Party in writing to the other, the Parties shall refer
such dispute to the Chief Executive Officer of each Party, or their designees,
for attempted resolution by good faith negotiations within thirty (30) days
after such notice is received.  If the
Chief Executive Officers of the Parties, or their designees, are not able to resolve
such dispute within


 


47

















 


such thirty (30) day
period, either Party may at any time thereafter invoke the provisions of Section 14.3.


 


14.3                        Arbitration. 
Any dispute, controversy or claim arising out of or relating to the
validity, construction, interpretation, enforceability, breach, performance,
application or termination of this Agreement that is not resolved pursuant to Section 14.2(b),
except for a dispute, claim or controversy under Section 14.4, shall be
settled by binding arbitration administered by the ICC pursuant to its Dispute
Resolution Rules then in effect (the “ICC Rules”),
except as otherwise provided herein.  The
arbitration shall be governed by the United States Federal Arbitration Act, 9
U.S.C. §§ 1-16 (the “Federal Arbitration Act”),
to the exclusion of any inconsistent state laws.  The United States Federal Rules of Civil
Procedure shall govern discovery and the Federal Rules of Evidence shall
be the rules of evidence for the arbitration.  The arbitration will be conducted in New
York, New York, and the Parties consent to the personal jurisdiction of the
United States federal courts for any case arising out of or otherwise related
to this arbitration, its conduct and its enforcement.  Any situation not expressly covered by this
Agreement shall be decided in accordance with the ICC Rules.


 


(a)                                  Panel. 
The arbitration panel (the “Panel”) shall
be composed of three (3) neutral, independent and impartial arbitrators
selected as follows from a pool of former federal judges to be presented to the
Parties by the ICC.  Each Party shall
select one (1) arbitrator and the arbitrators selected by the Parties
shall select the third arbitrator, who shall serve as chairman of the Panel,
provided that if the first two arbitrators cannot agree on the selection of the
third arbitrator within ten (10) days, the third arbitrator shall be
selected by the ICC.


 


(b)                                  Decision. 
The power of the Panel to fashion procedures and remedies within the
scope of this Agreement is recognized by the Parties as essential to the
success of the arbitration process.  The
Panel shall not have the authority to fashion remedies that would not be
available to a federal judge hearing the same dispute.  The Panel is encouraged to operate on this
premise in an effort to reach a fair and just decision.  Reasons for the Panel’s decisions should be
complete and explicit, including all determinations of law and fact.  The written reasons should also include the
basis for any damages awarded and a statement of how the damages were
calculated.  Such a written decision
shall be rendered by the Panel following a full comprehensive hearing, no later
than twelve (12) months following the selection of the Panel as provided for in
Section 14.3(a).


 


(c)                                  Award. 
Any award shall be promptly paid in Dollars free of any tax, deduction
or offset; and any costs, fees or taxes incident to enforcing the award shall,
to the maximum extent permitted by law, be charged against the Party resisting
enforcement.  If as to any
issue the Panel should determine under applicable Laws that the position taken
by a Party is frivolous or otherwise irresponsible or that any wrongdoing the
Panel finds is in callous disregard of law and equity or the rights of the
other Party, the Panel shall also award an appropriate allocation of the
adversary’s reasonable attorney fees, costs and expenses to be paid by the
offending Party, the precise sums to be determined after a bill of attorney
fees, expenses and costs consistent with such award has been presented
following the award on the merits.  Each
Party agrees to abide by the award rendered in any arbitration conducted
pursuant to this Article 14, and agrees that, subject to the Federal
Arbitration Act, judgment may be entered upon


 


48

















 


the
final award in any court of competent jurisdiction in accordance with the
Convention on the Recognition and Enforcement of Foreign Arbitral Awards of
1958, and that other courts may award full faith and credit to such judgment in
order to enforce such award.  The award
shall include interest from the date of any damages incurred for breach of the
Agreement, and from the date of the award until paid in full, at a rate fixed
by the Panel.  With respect to money
damages, nothing contained herein shall be construed to permit the Panel or any
court or any other forum to award punitive or exemplary damages.  By entering into this agreement to arbitrate,
the Parties expressly waive any claim for punitive or exemplary damages.


 


(d)                                  Costs. 
Except as set forth in Section 14.3(c), each Party shall bear its
own legal fees.  The Panel shall assess its costs, fees and expenses
against the Party losing the arbitration unless he or she believes that neither
Party is the clear loser, in which case the Panel shall divide its fees, costs and expenses
according to its sole discretion.


 


(e)                                  Injunctive Relief. 
Provided a Party has made a sufficient showing under the rules and
standards set forth in the Federal Rules of Civil Procedure and applicable
case law, the Panel shall have the power to invoke, and the Parties agree
to abide by, injunctive measures after either Party submits in writing for
arbitration claims requiring immediate relief.  
Additionally, nothing in this Article 14 will preclude either Party
from seeking equitable relief or interim or provisional relief from a court of
competent jurisdiction, including a temporary restraining order, preliminary
injunction or other interim equitable relief, concerning a dispute either prior
to or during any arbitration if necessary to protect the interests of such
Party or to preserve the status quo pending the arbitration proceeding.


 


(f)                                    Confidentiality. 
The arbitration proceeding shall be confidential and the Panel shall issue appropriate protective orders
to safeguard each Party’s Confidential Information.  Except as required by law, neither Party
shall make (or instruct the Panel to make) any public announcement with respect to the
proceedings or decision of the Panel without prior written consent of the other
Party.  The existence of any dispute
submitted to arbitration, and the award, shall be kept in confidence by the
Parties and the Panel, except as required in connection with the
enforcement of such award or as otherwise required by applicable law.


 


(g)                                 Survivability. 
Any duty to arbitrate under this Agreement shall remain in effect and be
enforceable after termination of this Agreement for any reason.


 


14.4                        Patent and Trademark Dispute
Resolution.   Any dispute,
controversy or claim relating to the scope, validity, enforceability or
infringement of any patent rights covering the manufacture, use, Development or
Commercialization of the Product or of any trademark rights relating to the
Product shall be submitted to a court of competent jurisdiction in the
jurisdiction in which such patent or trademark rights were granted or arose.


 


ARTICLE 15

MISCELLANEOUS


 


15.1                        Entire Agreement; Amendment. 
This Agreement, including the Exhibits hereto, sets forth the complete,
final and exclusive agreement and all the covenants, promises, agreements,
warranties, representations, conditions and understandings between the Parties


 


49

















 


hereto with respect to
the subject matter hereof and supersedes, as of the Effective Date, all prior
agreements and understandings between the Parties with respect to the subject
matter hereof, including, without limitation, the Confidentiality Agreement
between the Parties, dated October 15, 2007.  There are no covenants, promises, agreements,
warranties, representations, conditions or understandings, either oral or
written, between the Parties other than as are set forth herein and
therein.  No subsequent alteration,
amendment, change or addition to this Agreement shall be binding upon the
Parties unless reduced to writing and signed by an authorized officer of each
Party.


 


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


 


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


 


	
  If to AMAG:

  	
  AMAG
  Pharmaceuticals, Inc.

  	
   

  
	
   

  	
  125
  CambridgePark Drive

  	
   

  
	
   

  	
  Cambridge, MA
  02140

  	
   

  
	
   

  	
  USA

  	
   

  
	
   

  	
  Attn: Legal
  Department

  	
   

  
	
   

  	
   

  	
   

  
	
  With a copy to:

  	
  Cooley Godward
  Kronish LLP

  	
   

  
	
   

  	
  One Freedom Square

  	
   

  
	
   

  	
  Reston Town
  Center

  	
   

  
	
   

  	
  11951 Freedom Drive

  	
   

  
	
   

  	
  Reston, VA 20190-5656

  	
   

  
	
   

  	
  Attn: Kenneth J. Krisko, Esq.

  	
   

  



 


50
















 


	
   

  	
  If to 3SBio:

  	
  3SBio Inc.,

  
	
   

  	
   

  	
  No. 3 A1 Road 10

  
	
   

  	
   

  	
  Shenyang
  Economy & Technology Development Zone

  
	
   

  	
   

  	
  Shenyang, 110027

  
	
   

  	
   

  	
  China

  
	
   

  	
   

  	
  Attn: David Chen

  
	
   

  	
   

  	
   

  
	
   

  	
  With a copy to:

  	
  Simpson Thacher & Bartlett LLP

  
	
   

  	
   

  	
  425 Lexington Avenue

  
	
   

  	
   

  	
  New York, NY 10017

  
	
   

  	
   

  	
  USA

  
	
   

  	
   

  	
  Attn: Noah M.
  Leibowitz, Esq.

  



 


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


 


15.5                        Assignment. 
Neither Party may assign or transfer this Agreement or any rights or
obligations hereunder without the prior written consent of the other, except
that (i) a Party may make such an assignment without the other Party’s
consent to an Affiliate (so long as such entity remains an Affiliate of the
transferee); (ii) 3SBio shall have the right to assign or transfer this
Agreement to a Third Party acquiror in connection with a Change of Control (as
defined below) subject to AMAG’s prior written consent, not to be unreasonably
withheld, conditioned, or delayed; and (iii) AMAG shall have the right to
assign or transfer this Agreement to a Third Party acquiror in connection with
a Change of Control subject to 3SBio’s right to practice the licenses under the
Collaboration Patents and AMAG Know-How granted in this Agreement in accordance
with the terms of this Agreement.  Any
permitted successor or assignee of rights and/or obligations hereunder shall,
in a writing to the other Party, expressly assume performance of such rights
and/or obligations.  The AMAG Know-How
shall exclude any intellectual property held or developed by a permitted
successor of AMAG not in connection with the Product.  Any assignment or attempted assignment by
either Party in violation of the terms of this Section 15.5 shall be null,
void and of no legal effect.  “Change of
Control” of a Party means the occurrence of one of the following events: (a) the
acquisition of such Party by, or consolidation or merger of such Party with,
any Third Party, in which the holders of such Party’s outstanding voting
securities immediately prior to such transaction own voting securities
representing less than fifty percent (50%) of the voting power of the
corporation or other entity surviving such transaction immediately after such
transaction; or (b) the sale or other transfer to a Third Party of all or
substantially all of such Party’s business.


 


15.6                        Performance by Affiliates. 
Except as otherwise provided in this Agreement, each Party may discharge
any obligations and exercise any rights hereunder through any of its
Affiliates.  Each Party hereby guarantees
the performance by its Affiliates of such Party’s obligations under this
Agreement, and shall cause its Affiliates to comply with the provisions of


 


51

















 


this Agreement in
connection with such performance.  Any
breach by a Party’s Affiliate of any of such Party’s obligations under this
Agreement shall be deemed a breach by such Party, and the other Party may
proceed directly against such Party without any obligation to first proceed
against such Party’s Affiliate.


 


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


 


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


 


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


 


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


 


15.11                 Counterparts. 
This Agreement may be executed in one (1) or more counterparts,
each of which shall be deemed an original, but all of which together shall
constitute one and the same instrument.


 


15.12                 Bankruptcy. 
The Parties intend that the licenses granted to 3SBio under this
Agreement shall be deemed licenses to “intellectual property” as that term is
defined in Section 101 of the Bankruptcy Code, and in the event of a
rejection of this Agreement by AMAG or its trustee in bankruptcy, 3SBio and its
Affiliates shall be have the right to exercise fully their rights under 11
U.S.C. § 365(n).


 


[Signature
page to follow.]


 


52

















 


IN WITNESS WHEREOF, the Parties have executed this
Collaboration and License Agreement by their duly authorized officers as of the
Effective Date.


 


	
  3SBIO
  INC.

  	
   

  	
  AMAG
  PHARMACEUTICALS, INC.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Jin Lou

  	
   

  	
  By:

  	
  /s/ Brian J.G.
  Pereira

  
	
   

  	
   

  	
   

  
	
  Name:

  	
  Jin Lou

  	
   

  	
  Name:

  	
  Brian J.G.
  Pereira

  
	
   

  	
   

  	
   

  
	
  Title:

  	
  Chief Executive
  Officer

  	
   

  	
  Title:

  	
  President &
  Chief Executive Officer

  
									



 

















 


EXHIBIT
A


PRODUCT
DESCRIPTION


 


[***]


 


[***]


 


[***]


 






[***]
INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 


A-1

















 


EXHIBIT
B


AMAG
HOUSE MARKS AND AMAG PRODUCT MARKS


 


AMAG
HOUSE MARKS


 


AMAG
PHARMACEUTICALS and all formulations of this name, including any stylized
representation of the letter “A”


 


AMAG
PRODUCT MARKS


 


[***]


 






[***]
INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 


B-1

















 


EXHIBIT
C


JOINT
STEERING COMMITTEE MEMBERS


 


AMAG


 


[***]


 


3SBio


 


[***]


 






[***] INDICATES
MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.


 


C-1

















 


EXHIBIT
D


INITIAL
INDICATION DEVELOPMENT PLAN


 


[***]


 






[***] INDICATES MATERIAL
THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED.
ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT
OF 1934, AS AMENDED.


 


D-1

















 


EXHIBIT E


SUPPLY
AGREEMENT


 


(SEE
ATTACHED)


 


E-1

















 


EXHIBIT F


3SBIO
CURRENT PRODUCT


 


Tietai Iron Sucrose Supplement   That certain product (irrespective of dosage
form or presentation) marketed by 3SBio as of the Effective Date known commonly
as Tietai Iron Sucrose Supplement.  Such
product is an intravenously administered prescription drug that is designed to
treat anemia associated with iron deficiency for patients with renal disease
and is distributed in 100 mg, 10 ml vials. 
Tietai Iron Sucrose Supplement was launched in China in 2005 by Borui. 3SBio
began to generate revenues from the sale of Tietai Iron Sucrose Supplement in
the beginning of 2007.


 


F-1

















 


EXHIBIT G


ARBITRATION
PROCEDURES FOR DISPUTES REFERRED FROM JSC


 


1.               If the Chief Executive Officers of the Parties, or
their designees, are unable to agree on any matter referred from the JSC within
the thirty (30)-day period referred to in Section 14.2(a), the Parties
will select a mutually agreeable arbitrator who has significant relevant experience
in the development and commercialization of pharmaceutical products, and no
affiliation or pre-existing relationship with either Party.  If the Parties cannot agree on an arbitrator
within 15 days after the termination of the 30-day period described in Section 14.2(a),
either Party may request the ICC to appoint an arbitrator with such experience
on behalf of the Parties in accordance with the ICC Rules.  The date on which such arbitrator is selected
will be the “Arbitration Commencement Date.” 
The arbitration shall be conducted in New York, New York, under the ICC
Rules, to the extent consistent with this Exhibit G.


 


2.               Within ten (10) business days after the
Arbitration Commencement Date, each Party will prepare and deliver to both the
arbitrator and the other Party its proposed resolution of the disputed matter
and a memorandum (the “Support Memorandum”) in support thereof.  The arbitrator will also be provided with a
copy of this Agreement.  Within ten (10) business
days after receipt of the other Party’s Support Memorandum, each Party may
submit to the arbitrator (with a copy to the other Party) a rebuttal to the
other Party’s Support Memorandum (a “Rebuttal”).  Neither Party may have communications (either
written or oral) with the arbitrator other than for the sole purpose of
engaging the arbitrator or as expressly permitted in this Exhibit G, or as
directed by the arbitrator.


 


3.               Within thirty (30) days after the Arbitration
Commencement Date, the arbitrator will select from the two proposed resolutions
provided by the Parties the resolution that he or she believes most accurately
reflects the intention of the Parties to this Agreement and the industry
customs regarding the development and commercialization of pharmaceutical
products (the “Selected Resolution”).  In
selecting a resolution, the arbitrator will take into consideration the Parties’
acknowledgement that AMAG possesses particular expertise and knowledge with
respect to Product Development (except for obtaining Regulatory Approval of the
Product in the Licensed Territory) and 3SBio possesses particular expertise and
knowledge with respect to Commercialization and obtaining Regulatory Approval
of the Product in the Licensed Territory. 
Therefore, the arbitrator will give due consideration to the relevant
expertise of each Party using Diligent Efforts in the Licensed Territory.  The Selected Resolution will become a binding
and enforceable obligation on the Parties.


 


4.               The arbitrator will have reasonable discretion to
request additional information, hold a hearing, and extend the time frame for
reaching his or her decision regarding the dispute at issue.  To the extent any further arbitration rules or
procedures are necessary for resolution of the dispute at issue, the ICC Rules will
apply.  Notwithstanding the foregoing,
the Parties are not required to select an arbitrator from the ICC panel of
arbitrators.  The arbitrator’s fees and
expenses will be paid by the Party whose proposed resolution is not selected by
the arbitrator.


 


G-1