Exhibit 10.1

 

[***] 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.

 

SUPPLY AGREEMENT

 

This SUPPLY AGREEMENT (the “Agreement”) is made and entered into as of the
1st day of February 2014 (the “Supply Agreement Effective Date”) by and between
(i) AMAG PHARMACEUTICALS, INC., a Delaware corporation with its principal place
of business at 1100 Winter Street, MA 02451, USA (“AMAG”), and (ii) TAKEDA
PHARMACEUTICALS INTERNATIONAL GMBH, a company incorporated under the laws of
Switzerland, with its principal place of business at Thurgauerstrasse
130,CH-8152 Glattpark-Opfikon (Zurich) (“Takeda”).  Takeda is an Affiliate of
Takeda Pharmaceutical Company Limited, a company incorporated under the laws of
Japan, with its principal place of business at 1-1, Doshomachi 4-chome, Chuo-ku,
Osaka, 540-8645, Japan (“TPC”).  AMAG and Takeda are sometimes referred to
herein individually as a “Party” and collectively as the “Parties”.

 

RECITALS

 

WHEREAS, AMAG and TPC have entered into that certain License, Development and
Commercialization Agreement, dated March 31, 2010, amended June 22, 2012 (the
“License Agreement”), pursuant to which AMAG granted TPC certain rights to
develop and commercialize AMAG’s proprietary product Feraheme® (ferumoxytol)
Injection in the Licensed Territory;

 

WHEREAS, pursuant to Article 7 of the License Agreement, AMAG and TPC agreed
that TPC would purchase Product from AMAG in finished form in unlabeled vials
for commercial use pursuant to a separate supply agreement and quality
agreement;

 

WHEREAS, AMAG and TPC have agreed pursuant to a letter agreement dated
February 01, 2014 (the “Letter Agreement”) that AMAG will supply Takeda with
such Product (and Takeda will purchase such Product) for use in accordance with
the terms and conditions of the License Agreement and this Agreement;

 

WHEREAS, TPC, Takeda Canada, Inc. (an Affiliate of TPC) and AMAG are parties to
that certain Quality Agreement, dated, for supply of the Product for Canada (the
“Canada Quality Agreement”), and Takeda Global Research & Development Centre
(Europe) Ltd., Takeda Italia Farmaceutici S.p.A. (now known as Takeda Italia
S.p.A.) and Takeda, each an Affiliate of TPC, and AMAG are parties to that
certain quality agreement, dated August 27, 2012, for supply of the Product for
the European Union and Switzerland, as amended from time to time by the parties
to such agreement (as amended, the “Technical Quality Agreement”); and

 

Whereas, the Parties desire to replace the Canadian Quality Agreement and the
Technical Quality Agreement for all future purchases and supplies of Product
made and effected according to this Agreement by a restated Quality Agreement
(the “Restated Quality Agreement”) to be negotiated between the Parties in good
faith and implemented in due course. It is hereby the Parties common
understanding that the Restated Quality Agreement shall

 

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[***] 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.

 

generally contain the same allocation of rights and obligations to each Party as
it is assigned in the Canadian Quality Agreement and/or the Technical Quality
Agreement respectively; and

 

WHEREAS, AMAG and TPC have previously entered into an Interim Canadian Supply
Agreement, dated March 22, 2012, and AMAG and Takeda have previously entered
into an Interim Supply Agreement for the EU, dated August 9, 2012 and an Interim
Supply Agreement for Switzerland, dated August 9, 2012 (collectively, the
“Interim Agreements”), which shall apply to and govern the supply of Product
under each such respective agreement (it being understood and agreed that this
Agreement shall apply to and govern the purchase of Product from and after the
Supply Agreement Effective Date for all countries in the Licensed Territory);

 

NOW THEREFORE, in consideration of the mutual promises and covenants set forth
below, Takeda and AMAG mutually agree as follows:

 

1.                                      DEFINITIONS.

 

Capitalized terms used but not defined herein shall have the meanings set forth
in the License Agreement.  As used in this Agreement, the following capitalized
terms shall have the following meanings:

 

1.1                               “Acceptance Tests” means those test methods as
and to the extent set forth in the Restated Quality Agreement to be performed to
determine that the Product supplied to Takeda conforms to the Drug Product
Specifications.

 

1.2                               “Adjusted Cap” shall have the meaning set
forth in Section 7.1(b).

 

1.3                               “AMAG Indemnitees” shall have the meaning set
forth in Section 9.1(b).

 

1.4                               “[***]” shall have the meaning set forth in
Section 7.6(a).

 

1.5                               “Baseline Materials Cost” shall have the
meaning set forth in Section 7.1(b).

 

1.6                               “Business Day” means (a) any Day excluding
Saturday, Sunday and all official national and local public holidays in either
(i) New York City, New York, USA or (ii) Denmark and (b) solely with respect to
the timing for delivery of Product hereunder, any Day excluding Saturday, Sunday
and all official national and local public holidays in the respective country of
the delivery location specified in the purchase order.

 

1.7                               “Capital Equipment” means any piece of
equipment with an original cost in excess of [***] and a useful life of more
than [***].

 

1.8                               “Change Control System” shall mean those
certain processes for developing, evaluating and implementing changes to Product
material and packaging specifications, packaging instructions, test methods,
manufacturing and sampling instructions and manufacturing records as and to the
extent set forth in the applicable Quality Agreement.

 

2

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[***] 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.

 

1.9                               “Claims” shall have the meaning set forth in
Section 9.1(a).

 

1.10                        “Commercial Supply Forecast” shall have the meaning
set forth in Section 2.2.

 

1.11                        “Customized Reference Standard” means any
non-compendial or not commercially available substance that has been shown by an
extensive set of analytical tests to be authentic material of high purity,
obtained from existing production material of high purity, or prepared by
further purification of existing production material.  A list of Customized
Reference Standards applicable to Acceptance Tests to be performed to determine
that the Product supplied to Takeda conforms to the Drug Product Specifications
is set forth in the Restated Quality Agreement.

 

1.12                        “Day” means calendar day.

 

1.13                        “Drug Product” means the Product in the form to be
supplied to Takeda in accordance with this Agreement, including the
Specifications.

 

1.14                        “Drug Product Intermediate” or “DPI” means
ferumoxytol used in the production of Drug Product for supply to the European
Union and Canada, and if applicable (that is, if a DPI is used for supply of
Drug Product to the following countries), to Switzerland and other countries, in
accordance with this Agreement, in each case, including the Specifications.

 

1.15                        “Drug Substance” means the Product in bulk form
prior to being formulated and packaged in the form required for delivery to
Takeda in accordance with this Agreement, including the Specifications.

 

1.16                        “DSS” or “Designated Second Source Supplier” means a
Third Party manufacturer of the Drug Substance, Drug Product Intermediate and/or
Drug Product as established in accordance with the License Agreement or pursuant
to Section 6.2.

 

1.17                        “EMA” means the European Medicines Agency.

 

1.18                        “Extended Price Period” shall have the meaning set
forth in Section 7.1(b).

 

1.19                        “Fully Burdened Manufacturing Cost” means the
consolidated fully burdened cost incurred by AMAG in the Manufacture of Product,
calculated in accordance with GAAP and with AMAG’s accounting practices applied
on a normal and customary basis by AMAG consistent with its practices, which
shall equal [***].

 

1.20                        “GAAP” means the generally accepted accounting
principles in the United States.

 

1.21                        “Harmonization”, with a correlative meaning for
“Harmonized”, means use of the manufacturing process approved by the EMA as of
June 22, 2012 or at any time during the term of this Agreement to manufacture
the Product for sale in the United States at the same manufacturing sites used
to manufacture the Product for sale in the Licensed Territory, but

 

3

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[***] 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.

 

excluding analytical testing not required by the FDA for the Product approved
for sale in the United States.

 

1.22                        “Harmonized Product” means any Product, manufactured
according to the Harmonized manufacturing process, by AMAG, or on AMAG´s behalf
by a DSS, intended for supply outside the Licensed Territory.

 

1.23                        “Indemnified Party” shall have the meaning set forth
in Section 9.1(c).

 

1.24                        “Indemnifying Party” shall have the meaning set
forth in Section 9.1(c).

 

1.25                        “Initial Price Period” shall have the meaning set
forth in Section 7.1(a).

 

1.26                        “Insolvency Event” shall have the meaning set forth
in Section 1.59 of the License Agreement.

 

1.27                        “Interim Product” shall have the meaning set forth
in Section 2.8.

 

1.28                        “Insolvency Transfer Event” shall have the meaning
set forth in Section 6.3(a).

 

1.29                        “License Agreement” shall have the meaning set forth
in the Recitals.

 

1.30                        “License Agreement Effective Date” means March 31,
2010.

 

1.31                        “MAA” means an application to the appropriate
Regulatory Authority for approval to market the Product (but excluding pricing
approvals) in any particular jurisdiction.

 

1.32                        “Manufacturing Site” means the manufacturing
facility of AMAG, its Affiliate or a DSS where Drug Substance, Drug Product
Intermediate and/or Drug Product is Manufactured for the Licensed Territory.

 

1.33                        “Manufacturing SOPs” means, as to a Product, the
specific methods, techniques, processes and standard operating procedures that
are to be used by AMAG or a DSS to Manufacture Drug Product, Drug Product
Intermediate and/or Drug Substance.

 

1.34                        “[***]” shall have the meaning set forth in
Section 7.6(a).

 

1.35                        “Minimum Order Quantity” shall have the meaning set
forth in Section 2.4.

 

1.36                        “MSDS” shall have the meaning set forth in
Section 3.11.

 

1.37                        “New Product Configuration” shall have the meaning
set forth in Section 2.7.

 

1.38                        “Non-Conformity” or “Non-Conforming” shall have the
meaning set forth in Section 5(a).

 

4

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[***] 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.

 

1.39                        “Party” or “Parties” shall have the meaning set
forth in the introductory paragraph.

 

1.40                        “Process Changes” shall have the meaning set forth
in Section 3.6(a).

 

1.41                        “Product” means any Product (as defined in the
License Agreement) then being Developed or Commercialized under the License
Agreement pursuant to the terms and conditions thereof, in finished form in
unlabeled vials and/or such other presentation as agreed by the Parties.

 

1.42                        “Product Price” shall have the meaning set forth in
Section 7.1.

 

1.43                        “Quality Agreements” shall have the meaning set
forth in Section 3.1.

 

1.44                        “Quality Control Procedures” shall have the meaning
set forth in Section 3.3.

 

1.45                        “[***] Materials Cost” shall have the meaning set
forth in Section 7.1(b).

 

1.46                        “Required Sites” shall have the meaning set forth in
Section 6.1.

 

1.47                        “Samples” means retained samples, reference samples
and stability samples of the Product, as applicable.

 

1.48                        “Specifications” means, with respect to a particular
regulatory jurisdiction in the Licensed Territory, upon MAA approval for such
jurisdiction, the characteristics for Drug Substance, Drug Product Intermediate
and Drug Product included in such MAA.  The Specifications as of the Supply
Agreement Effective Date are set forth in the Restated Quality Agreement, and
the Parties shall amend such Specifications from time to time upon any MAA
approval in the Licensed Territory or amendment of any Specifications pursuant
to Section 3.6.

 

1.49                        “Takeda Indemnitees” shall have the meaning set
forth in Section 9.1(a).

 

2.                                      PURCHASE AND SUPPLY.

 

2.1                               Purchase and Supply Agreement.  During the
term of this Agreement, Takeda agrees to buy, and AMAG agrees to sell, all of
Takeda’s and its Affiliates’ and their respective sublicensees’ requirements of
Product for commercial use under the License Agreement for the Licensed
Territory, in accordance with the terms and conditions of this Agreement
(including without limitation, the Quality Agreements, each of which shall be
incorporated herein by reference whether or not attached hereto) and the License
Agreement.  Takeda shall have the right to use Product ordered under this
Agreement for clinical use; provided that (a) such Product shall be subject to
all of the terms and conditions of this Agreement, including the Specifications
applicable to commercial supply, and (b) if Takeda desires that AMAG supply
Product to Takeda for clinical use that is different from the Drug Product that
AMAG is then supplying for commercial use under this Agreement, the Parties will
discuss in good faith and enter into, each

 

5

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[***] 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.

 

in its sole discretion, a different arrangement governing such supply.  All
Product supplied by or on behalf of AMAG under this Agreement will be supplied
in finished form in unlabeled vials, or as otherwise agreed by the Parties. 
Takeda shall be solely responsible for labeling and packaging such vials in
accordance with the terms of this Agreement (including without limitation the
Quality Agreements) and the License Agreement.

 

2.2                               Commercial Supply Forecasts.

 

(a)                                 On or before the Supply Agreement Effective
Date, Takeda shall deliver to AMAG a detailed forecast of Takeda’s requirements
for Product for commercial use to be delivered in each month of the [***] period
beginning with the first full calendar month following the date on which such
forecast is delivered to AMAG (a “Commercial Supply Forecast”).  Takeda shall
thereafter provide an updated Commercial Supply Forecast on a monthly basis no
later than five (5) Days before the end of each calendar month, so that prior to
the beginning of each calendar month, AMAG shall have been provided with an
updated rolling detailed Commercial Supply Forecast for each month during the
subsequent [***] period.  Each such Commercial Supply Forecast shall be
reasonably consistent with Takeda’s projected commercial sales of the Product in
the Licensed Territory on a monthly basis.  The first [***] of each Commercial
Supply Forecast will correspond to Product ordered in accordance with
Section 2.4 prior to the delivery of such Commercial Supply Forecast.  The [***]
of each Commercial Supply Forecast will be binding. The quantities indicated for
the remaining [***]of each Commercial Supply Forecast will be treated as a
forecast only and will not create any obligations for either Party, provided
that the quantities set forth in the [***] month of any Commercial Supply
Forecast may not exceed or be less than the quantity set forth for such [***] in
the immediately prior Commercial Supply Forecast by [***], whichever is larger. 
An illustration of the foregoing forecasting/ordering process is set forth in
Exhibit B.

 

(b)                                 AMAG shall promptly notify Takeda of any
problems of which AMAG becomes aware that could reasonably be expected to
prevent AMAG from providing timely deliveries of Product in accordance with
Takeda’s forecast amounts, and the Parties shall cooperate in resolving such
problems relating to the Manufacture and supply of Product under this Agreement.

 

2.3                               Supply in Excess of Forecast.  Takeda may
order Product for commercial use in excess of the binding portion of any
Commercial Supply Forecast, and AMAG shall supply to Takeda up to [***] of such
binding portion as ordered, rounded up to an integer multiple of the applicable
Minimum Order Quantity.  If Takeda orders more than such amount, AMAG shall use
Commercially Reasonable Efforts to supply such additional amounts ordered,
subject to Section 2.6 and to the Parties’ agreement on any Capital Equipment
acquisitions necessary to enable AMAG or its DSS to supply such additional
amounts.

 

2.4                               Ordering.  All Product ordered under this
Agreement shall be pursuant to written purchase orders, each of which shall
specify the quantity of Product ordered and the requested delivery date.  Except
for orders for the Interim Product, the minimum quantity of Product

 

6

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[***] 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.

 

ordered in each purchase order for commercial supply shall be as set forth in
Exhibit D (as applicable, the “Minimum Order Quantity”), unless agreed otherwise
in writing by the Parties.  The quantity of Product ordered in each purchase
order, other than orders for Interim Product, shall be a multiple of the
applicable Minimum Order Quantity.  At the request of either Party, the Parties
shall meet and discuss in good faith reasonable changes to the applicable
Minimum Order Quantity in response to (i) changes to the Specifications or
manufacturing process for a Product for the Licensed Territory, (ii) Product
characteristics that are specific to the Product supplied for a particular
regulatory jurisdiction in the Licensed Territory, or (iii) Takeda’s ability to
market a Product with particular characteristics in additional regulatory
jurisdictions in the Licensed Territory.  Except for purchase orders for Interim
Product, Takeda shall submit each such purchase order to AMAG no later than
[***] prior to the delivery date indicated in such purchase order.  Any purchase
orders for Product submitted by Takeda will be governed exclusively by the terms
contained herein and the License Agreement.  Any term or condition in any order,
confirmation or other document furnished by Takeda or AMAG that is in any way
inconsistent with the terms and conditions of this Agreement or the License
Agreement is hereby expressly rejected, unless expressly agreed otherwise in
writing by the Parties.  Within fifteen (15) Days after receipt of a purchase
order placed in accordance with this Section 2.4, AMAG shall confirm or decline
in writing such purchase order; provided, however, that AMAG may decline such
purchase order only with respect to any quantities of the Product that are in
excess of the permissible variance under Section 2.3.  AMAG will be deemed to
have accepted any purchase order not confirmed or declined within such seven
(7)-Day period.  All purchase orders confirmed by AMAG are binding and may not
be cancelled unless otherwise agreed in writing by AMAG.

 

2.5                               Product Allocation Upon Insufficient Supply. 
In addition to Takeda’s rights under Section 6.3(a)(ii) and (iii), if AMAG is
unable, for any reason beyond its reasonable control (including an unanticipated
increase in demand for the Product beyond the production capacity of the
Manufacturing Sites), to supply sufficient quantities of the Product to meet
(i) the binding portion of Takeda’s then-current Commercial Supply Forecast for
the Licensed Territory and (ii) AMAG’s previously forecasted requirements for
Harmonized Product for supply outside the Licensed Territory which AMAG is
unable to fulfill from manufacturing facilities other than the Manufacturing
Sites, then AMAG shall promptly establish an allocation procedure with respect
to the total available supply of the Product and Harmonized Product from the
Manufacturing Sites for the Licensed Territory and outside the Licensed
Territory, which will provide the following allocations to Takeda:

 

(a)                                 First, an amount of the Product and
Harmonized Product from the Manufacturing Sites sufficient to satisfy any
warranty obligation to replace Non-Conforming Product which AMAG may owe to
Takeda at the time of such allocation; provided, however, that if the total
available supply of Product and Harmonized Product from the Manufacturing Sites
is insufficient to satisfy such obligation to Takeda plus all of AMAG’s similar
warranty obligations outside the Licensed Territory for Harmonized Products,
then this allocation shall be made pro rata on a unit basis among all such
warranty obligations.

 

7

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[***] 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)                                 Second, an amount of the Product and
Harmonized Product from the Manufacturing Sites sufficient to satisfy any
backlog from Takeda’s previous binding purchase orders for Product and
Harmonized Product that AMAG may owe to Takeda at the time of such allocation;
provided, however, that if the total available supply of Product and Harmonized
Product from the Manufacturing Sites is insufficient to satisfy such obligation
to Takeda plus all of AMAG’s similar obligations outside the Licensed Territory
for Harmonized Products, then this allocation shall be made pro rata on a unit
basis among all such obligations.

 

(c)                                  Third, a fraction of the remaining supply
of the Product and Harmonized Product from the Manufacturing Sites (if any), the
numerator of which fraction shall be the aggregate quantity of the Product which
Takeda has projected that it will purchase from AMAG during [***], as determined
by Takeda’s latest purchase orders and Commercial Supply Forecasts submitted to
AMAG for such [***], and the denominator of which fraction shall be the
aggregate quantity of the Product and the Harmonized Product from the
Manufacturing Sites which all parties (including AMAG and Takeda) have projected
that they will purchase from AMAG during the [***] and which AMAG would be
expected to supply from the Manufacturing Sites, as determined by such parties’
latest binding orders and estimates (including those of AMAG itself relating to
AMAG’s internal demand forecasts) submitted to AMAG for such [***].

 

If AMAG is prevented from providing timely deliveries of Product in accordance
with Takeda’s binding forecast amounts, then:

 

AMAG shall promptly -and in addition to the allocation procedure described under
Sections 2.5 (a), (b) and (c)- establish an allocation procedure with respect to
the total available supply of AMAG’s future manufacturing slots at the
Manufacturing Sites for manufacture of (i) the Product and Harmonized Product
from the Manufacturing Sites for the Licensed Territory and outside the Licensed
Territory and (ii) drug product of Feraheme® (ferumoxytol) Injection
manufactured by AMAG for sale in the U.S.A. (“U.S.A. Drug Product”), from the
Manufacturing Sites until timely deliveries of Product to Takeda are resumed. 
Such allocation shall provide the following allocations of such future
manufacturing slots to be devoted to the manufacture of Product for Takeda:

 

(d)                                 First, an amount of AMAG’s future
manufacturing slots at the Manufacturing Sites sufficient to satisfy any
warranty obligation to replace Non-Conforming Product which AMAG may owe to
Takeda at the time of such allocation; provided, however, that if the total
available supply of AMAG’s future manufacturing slots at the Manufacturing Sites
is insufficient to satisfy such obligation to Takeda plus all of AMAG’s similar
warranty obligations outside the Licensed Territory for Harmonized Products,
then this allocation shall be made pro rata on a unit basis among all such
warranty obligations; and

 

(e)                                  Second, an amount of AMAG’s future
manufacturing slots at the Manufacturing Sites sufficient to satisfy any backlog
from Takeda’s previous binding purchase orders for Product and Harmonized
Product that AMAG may owe to Takeda at the time of such

 

8

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[***] 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.

 

allocation; provided, however, that if the total available supply of AMAG’s
future manufacturing slots at the Manufacturing Sites is insufficient to satisfy
such obligation to Takeda plus all of AMAG’s similar obligations outside the
Licensed Territory for Harmonized Products, then this allocation shall be made
pro rata on a unit basis among all such obligations.

 

(f)                                   Third, a fraction of the remaining of
AMAG’s future manufacturing slots at the Manufacturing Sites, the numerator of
which fraction shall be the aggregate quantity of the Product which Takeda has
projected that it will purchase from AMAG during the [***], as determined by
Takeda’s latest purchase orders and Commercial Supply Forecasts submitted to
AMAG for such [***] and the denominator of which fraction shall be the aggregate
quantity of the Product, the Harmonized Product and U.S.A Drug Product from the
Manufacturing Sites which all parties (including AMAG and Takeda) have projected
that they will purchase from AMAG during the [***] and which AMAG would be
expected to supply from the Manufacturing Sites, as determined by such parties’
latest binding orders and estimates (including those of AMAG itself relating to
AMAG’s internal demand forecasts of U.S.A. Drug Product) submitted to AMAG for
such [***].  AMAG will use Commercially Reasonable Efforts to work with DSSs to
re-allocate such future manufacturing slots at the Manufacturing Sites in
accordance with such allocation.

 

Each of AMAG and Takeda shall cooperate in resolving such problems relating to
the Manufacture and supply of Product under this Agreement and to reduce the
impact of such circumstances.

 

AMAG shall use Commercially Reasonable Efforts to avoid any circumstances that
would require allocation under this Section 2.5 and to reduce the impact of such
circumstances as soon as reasonably practicable if they arise.  Should such
circumstances arise, AMAG shall promptly notify Takeda in writing, and the
Parties shall cooperate in developing a plan to avoid, resolve or reduce the
impact of such problems relating to the Manufacture and supply of Product under
this Agreement.  Such plan will be designed to address the period of
insufficient supply of the Product occurring in the ordered and binding portions
of Takeda’s then-current Commercial Supply Forecast ([***]) for the Licensed
Territory according to this Section 2.5.  AMAG will use Commercially Reasonable
Efforts to work with DSSs to supply timely deliveries of Product to Takeda as
soon as reasonably practicable.

 

2.6                               Capital Equipment and Manufacturing Fees.

 

(a)                                 Capital Equipment Purchases Before the
Supply Agreement Effective Date. Takeda shall reimburse AMAG in accordance with
Section 2.6(b) for those Capital Equipment expenditures incurred after the
License Agreement Effective Date and prior to the Supply Agreement Effective
Date in the amounts set forth in Exhibit E.

 

(b)                                 Manufacturing Fees.  For any Capital
Equipment to be reimbursed by Takeda in accordance with Section 2.6(a) or
Section 2.6(c) or Section 2.6(d) of this Agreement, AMAG shall invoice and
Takeda shall pay AMAG a fee per unlabeled vial (the “Manufacturing Fee”)
determined in accordance with this Section 2.6(b), provided that such
Manufacturing Fee

 

9

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[***] 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.

 

shall be payable as described in Section 7.2, subject to the true-up procedure
described in Section 7.3(b), and subject to the remaining terms and conditions
set forth in Article 7.  AMAG shall invoice Takeda for all Capital Equipment to
be reimbursed in accordance with Section 7.2 of this Agreement during any given
calendar year at Manufacturing Fee per vial.  For each calendar year, at the
time of each shipment of Product hereunder, AMAG shall provide to Takeda a
written invoice for Product supplied in such delivery with the Manufacturing Fee
payable per vial of Product being equal to the average amount per vial of the
total aggregate amount any Capital Equipment to be reimbursed by Takeda from the
prior calendar year that would be payable hereunder if, during the course of
such calendar year, Takeda purchased the number of vials forecast in the last
Commercial Supply Forecast for such calendar year provided by Takeda to AMAG
prior to commencement of such calendar year.

 

(c)                                  Capital Equipment Purchases After the
Supply Agreement Effective Date.  AMAG shall notify Takeda in writing describing
in detail any Capital Equipment proposed to be acquired by AMAG after the Supply
Agreement Effective Date for use in supplying Product to Takeda for which Takeda
would bear [***].  Takeda will be responsible to AMAG for any Capital Equipment
expenditures (all without markup by AMAG) made after the Supply Agreement
Effective Date to the extent attributable to AMAG’s supply of Product to Takeda
for the Licensed Territory where Takeda agrees to such Capital Equipment
expenditures or to the extent that such Capital Equipment purchase is reasonably
necessary for the manufacture of the Product for the Licensed Territory.  Within
thirty (30) Days after Takeda’s receipt of such notice, the Parties shall meet
and discuss in good faith AMAG’s acquisition and use of such Capital Equipment. 
For any such equipment, the Parties shall reasonably allocate between the
Parties the Capital Equipment expenditures [***], in each case for the [***],
and shall determine a schedule for Takeda’s payment of its portion of such
Capital Equipment expenditures in accordance with Section 2.6(b) of this
Agreement, provided that in any event Takeda shall pay such portion in full by
no later than the end of the following fiscal year after the end of such thirty
(30)-Day period.  Any dispute between the Parties over whether such Capital
Equipment is reasonably necessary to the manufacture of the Product for the
Licensed Territory will be resolved in accordance with Section 12.1 of this
Agreement.  The Parties shall agree on a written budget for any Capital
Equipment expenditure to be incurred in accordance with this Section 2.6(c).

 

(d)                                 Invoices.  AMAG shall include Takeda’s
portion of such Capital Equipment expenditures in the invoices provided pursuant
to Section 7.2, in accordance with the applicable payment schedule, and Takeda
shall pay such invoices as provided in such section.

 

(e)                                  Risk of Loss; Insurance.  For clarity, any
such Capital Equipment expenditures and Manufacturing Fees are not included in
the Fully Burdened Manufacturing Cost, and all Capital Equipment will be solely
owned by AMAG and/or its designee.  AMAG shall be responsible to either obtain
insurance or self-insure against any losses to such Equipment.  AMAG shall be
responsible for any risk of catastrophic loss (e.g., fire, flood or theft) of
such Capital Equipment.  Notwithstanding the foregoing, the replacement, repair
and/or servicing of any Capital Equipment due to normal wear and tear,
mechanical problems or

 

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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.

 

obsolescence would be deemed Capital Equipment expenditures and reimbursement
would be governed by Section 2.6(c) of this Agreement.

 

2.7                               New Product Configuration.  Except for Process
Changes addressed in Section 3.6, if Takeda desires that AMAG supply a Product
not within the scope of the Specifications, such as in a package size or dosage
form specific to the Licensed Territory, (“New Product Configuration”), Takeda
shall notify AMAG, and the Parties shall promptly meet and discuss in good faith
such proposed New Product Configuration, a reasonable means for supplying such
New Product Configuration, the terms of such supply, and a written budget for
costs (all without markup by AMAG) to implement and supply such New Product
Configuration with such budget to include all anticipated Third Party and AMAG
internal costs.  If a budget and the terms and conditions of such supply is
agreed, AMAG shall use Commercially Reasonable Efforts to satisfy Takeda’s New
Product Configuration supply needs itself or through one or more DSS in
accordance with such budget.  Takeda shall be solely responsible for the
budgeted costs incurred by AMAG in connection with such activities; provided
however, that Takeda shall not be obligated to reimburse, and AMAG shall not be
obligated to conduct, any activities whose costs exceed the agreed budget.  If
the implementation of the New Product Configuration results in increased profit
to AMAG under this Agreement, or increased profit to AMAG on sales of the New
Product Configuration outside the Licensed Territory, then the Parties will
negotiate in good faith towards a reasonable allocation between the Parties of
the costs borne by Takeda for the New Product Configuration and AMAG will
provide a credit equal to its agreed upon allocation of such costs against
amounts that become due hereunder until such credited amount is fully applied.

 

2.8                               Interim Product.  In addition to the amounts
set forth in the Commercial Supply Forecast and ordered in accordance with
Section 2.4, with respect to Product described in this Section 2.8 and in
Exhibit A (collectively, the “Interim Product”) and for which (i) the quality
control release by AMAG is issued no later than [***] and (ii) the variation to
extend shelf life is approved by [***], the following shall apply: (a) Takeda
shall be required to purchase all such Interim Product as was manufactured for
use in [***] and (b) Takeda shall have the right, but not the obligation, to
purchase all such Interim Product as was manufactured for use in [***], provided
that Takeda provides written notice to AMAG prior to [***] of Takeda’s
commitment to purchase such Interim Product as was manufactured for use in [***]
(if Takeda determines not purchase such Interim Product as was manufactured for
use in [***], Takeda shall provide written notice promptly to AMAG).  Takeda
shall submit a purchase order for such Interim Product as was manufactured for
use in [***] within [***] after the quality control release by AMAG.  For any
Interim Product as was manufactured for use in [***] that Takeda purchases under
this Section 2.8, Takeda shall submit purchase orders in accordance with
Section 2.4, except that the delivery date for such orders shall be at least
five (5) business Days after AMAG’s receipt of the purchase order.

 

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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.

 

3.                                      MANUFACTURE; REGULATORY.

 

3.1          Quality Agreements. The Canada Quality Agreement governs the
quality assurance obligations and responsibilities of the Parties with respect
to the Manufacture and supply of the Product for commercial use in Canada which
was ordered and supplied prior to the Effective Date of this Agreement, and the
Technical Quality Agreement governs the quality assurance obligations and
responsibilities of the Parties with respect to the Manufacture and supply of
the Product for commercial use in the European Union and Switzerland which was
ordered and supplied prior to the Effective Date of this Agreement the “Quality
Agreements”).  For the future purchases and supplies of Products based on the
stipulations set forth in this Agreement  the Parties shall negotiate in good
faith and enter into the Restated Quality Agreement. Such Restated Quality
Agreement shall generally contain the same allocation of rights and obligations 
to each Party as it is assigned in the Canadian Quality Agreement and/or the
Technical Quality Agreement respectively. In the event of a discrepancy between
the provisions of a Quality Agreement/Restated Quality Agreementand the
provisions of this Agreement or the Manufacturing SOPs, the provisions of the
Quality Agreements/Restated Quality Agreement shall control with respect to
terms governing quality of the Product, and the provisions of this Agreement
shall control with respect to any other conflicting terms between such
agreements.

 

3.2          Product Specifications; Testing and Customized Reference
Standards.  AMAG or its designee shall test each batch of Product in accordance
with the Acceptance Tests prior to shipment and shall include with each shipment
of Product an original certificate of analysis confirming that such batch meets
the Drug Product Specifications.  Upon receipt of Product, Takeda shall conduct
applicable tests of Product in accordance with the applicable Quality Agreement
and to the extent required by a Regulatory Authority in the Licensed Territory. 
AMAG shall transfer to Takeda all information related to the Product reasonably
necessary for and requested by Takeda to perform quality testing required by
applicable Laws or a Regulatory Authority in the Territory; provided that the
foregoing shall not obligate AMAG to conduct technology transfer of any methods.
AMAG shall provide to Takeda reasonable quantities of any Customized Reference
Standard necessary to enable Takeda to perform applicable tests of Product in
accordance with the Restated Quality Agreement and to the extent required by a
Regulatory Authority in the Licensed Territory.  For all Customized Reference
Standards delivered to Takeda, Takeda shall promptly reimburse AMAG for [***]
incurred in the course of manufacturing, testing and releasing such standards.
Takeda shall monitor consumption of such Customized Reference Standards and
shall order further supply of Customized References Standards from AMAG. AMAG
shall deliver to Takeda Customized Reference Standards within [***] from receipt
of an acceptable Purchase Order from Takeda. Delivery shall be made FCA
(Incoterms 2010).  Customized Reference Standards shall be stored by Takeda in
accordance with AMAG’s recommended storage conditions and used within their
given expiry or retest date as provided by AMAG.

 

3.3          Quality Control.  AMAG will (or will ensure that its DSS will)
maintain and follow a quality assurance and quality control testing program
consistent with the Specifications,

 

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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.

 

cGMP, and all other requirements of applicable Laws and consistent with the
Quality Agreements (the “Quality Control Procedures”), which will include
performing the applicable Acceptance Tests on each batch of Product supplied to
Takeda pursuant to Section 3.2.  AMAG shall ensure that all Product supplied to
Takeda hereunder is manufactured, processed, stored, tested, transported and
otherwise handled in accordance with Section 8.3(i).

 

3.4          Regulatory Inspections.  Upon the request of any Regulatory
Authority having jurisdiction over the manufacture of Product for the Licensed
Territory, AMAG shall allow such Regulatory Authority access to observe and
inspect AMAG’s or its DSS’ facility for manufacturing Product and procedures
used for the manufacture, packaging, release and stability testing, and/or
warehousing of Product and to audit such facilities for compliance with cGMP
and/or other applicable Laws.  AMAG shall cooperate (and shall use Commercially
Reasonable Efforts to ensure that its DSS cooperates) with any inspection by a
Regulatory Authority having jurisdiction over the manufacture of Product for the
Licensed Territory, whether prior to or after Regulatory Approval of a Product,
and to notify Takeda of any written or oral notifications or inspection activity
by any Regulatory Authority or other governmental agency or authority of
competent jurisdiction that relates to the manufacture of Product supplied for
the Licensed Territory to Takeda hereunder in accordance with the Quality
Agreements.  The Parties agree that each Party shall have the right to have no
more than three (3) representatives observe, as witnesses, any such inspection
by a Regulatory Authority relating to the manufacture or testing of the Product,
subject to the limitations regarding the disclosure of CMC Information set forth
in this Agreement and/or the License Agreement.

 

3.5          Quality Assurance Audits.  The Parties’ rights and obligations with
respect to quality assurance audits are as set forth in the Quality Agreements.

 

3.6          Change in Specifications or Manufacturing Process.

 

AMAG shall not make any material changes to the Specifications or to the
materials, equipment, process or procedures used to manufacture Product for the
Licensed Territory (“Process Changes”) without Takeda’s prior written consent,
which consent shall not be unreasonably withheld or delayed.  For clarity, a
material change shall be any change that must be approved by a Regulatory
Authority, as described in the Restated Quality Agreement. AMAG shall manage all
Process Changes in accordance with its Change Control System and the applicable
Quality Agreement and shall keep Takeda informed of the progress of such
changes.  Upon any change to the Specifications, the Parties shall amend the
Restated Quality Agreement accordingly.

 

(a)           If, after the Supply Agreement Effective Date, a Regulatory
Authority requires a Process Change as a condition for obtaining or maintaining
Regulatory Approval for the Product in the Licensed Territory (“Regulatory
required Process Change”), Takeda shall promptly notify AMAG, and the Parties
shall meet and discuss how to implement such requirement.  AMAG shall use
Commercially Reasonable Efforts to accommodate such Process Change and, if AMAG
implements such Process Change, shall use Commercially Reasonable

 

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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.

 

Efforts to do so in a cost-effective manner.  If, as a result of such change,
the Fully Burdened Manufacturing Cost exceeds the applicable Cap or Adjusted
Cap, then [***], notwithstanding anything to the contrary in this Agreement. 
With respect to any expenses incurred by AMAG in connection with such Process
Change that are not included in the Fully Burdened Manufacturing Cost:
(i) Capital Equipment expenditures will be shared as provided in Section 2.6 and
(ii) Takeda shall [***].  In addition, Takeda shall [***].

 

(b)           If, after the Supply Agreement Effective Date, AMAG requests a
Process Change that is not required to obtain or maintain Regulatory Approval
for the Product in the Licensed Territory and other than Process Changes
addressed in Section 3.6(d) of this Agreement, promptly, and in any event within
thirty (30) Days, following AMAG’s written notice of a proposed Process Change,
the Parties shall meet and discuss such proposal in good faith.  If Takeda
determines that it will not grant such consent to a Process Change, Takeda shall
promptly notify AMAG following such determination, provide an explanation of its
concerns and use Commercially Reasonable Efforts to cooperate with AMAG on an
implementation of such Process Change that would be acceptable to Takeda, not
later than forty-five (45) Days after receipt of written notice from AMAG of the
proposed Process Change, however Takeda shall not be deemed to have given its
consent to such requested Process Change if Takeda shall fail to provide its
concerns within the forty-five Days period. If the Parties agree to make such
Process Change, then AMAG shall use Commercially Reasonable Efforts to implement
such Process Change in a cost-effective manner. With respect to any expenses
incurred by AMAG in connection with such Process Change that are not included in
the Fully Burdened Manufacturing Cost, [***].

 

(c)          If, after the Supply Agreement Effective Date, Takeda requests a
Process Change that is not required to obtain or maintain Regulatory Approval
for the Product in the Licensed Territory, the Parties shall meet and discuss
such proposal in good faith.  AMAG shall use Commercially Reasonable Efforts to
accommodate such Process Change and, if AMAG implements such Process Change,
shall use Commercially Reasonable Efforts to do so in a cost-effective manner. 
If as a result of such change, the Fully Burdened Manufacturing Cost exceeds the
applicable Cap or Adjusted Cap, [***], notwithstanding anything to the contrary
in this Agreement.  With respect to any expenses incurred by AMAG in connection
with such Process Change that are not included in the Fully Burdened
Manufacturing Cost: (i) Capital Equipment expenditures will be shared as
provided in Section 2.6 and (ii) Takeda shall [***].

 

(d)           If, after the Supply Agreement Effective Date, either Party
proposes a Process Change that is not required to obtain or maintain Regulatory
Approval for the Product in the Licensed Territory, but which is in the view of
the proposing Party to be deemed to create any economical advantages for both
Parties (including, but not limited to, reducing the Fully Burdened
Manufacturing Cost, improving reliability of supply, or reducing lead time for
manufacturing) , the Parties shall meet and discuss such proposal in good
faith.  AMAG shall use Commercially Reasonable Efforts to accommodate such
Process Change and, if AMAG implements such Process Change, shall use
Commercially Reasonable Efforts to do so in a cost-

 

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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.

 

effective manner.  If as a result of such change, the Fully Burdened
Manufacturing Cost exceeds the applicable Cap or Adjusted Cap, then such excess
costs will [***].

 

3.7          Compliance with Laws.  AMAG shall comply, and shall use
Commercially Reasonable Efforts to ensure and to require that its DSSs shall
comply, with all Laws applicable to the manufacture, processing, storage,
testing, transport, disposal and other handling of Product by AMAG and its DSSs
under this Agreement.  AMAG will maintain, and will require its DSS to maintain,
during the term of this Agreement, all government permits, including without
limitation health, safety and environmental permits, necessary for AMAG to
supply the Product to Takeda in accordance with this Agreement.  Takeda shall
provide AMAG with written notice of any additional regulatory requirements that
relate to the manufacture of Product for the Licensed Territory.  If such
requirements necessitate a change to the Specifications, the Parties shall
proceed in accordance with Section 3.6.

 

3.8          Documentation and Samples.  Each Party shall maintain complete,
accurate and authentic accounts, notes, data and records pertaining to the
methods and facilities such Party uses for the manufacture, processing, testing,
packing, labeling, holding and distribution (as applicable) of the Product, in
accordance with applicable Laws.  Subject to AMAG’s right to limit disclosure of
CMC Information in accordance with the terms of the License Agreement, each
Party shall make such records available to the other Party for inspection
promptly following receipt of the other Party’s written request, and shall make
available to such other Party copies of such records, provided that AMAG may
redact CMC Information from such records in accordance with the terms of the
License Agreement.  The Parties’ rights and obligations with respect to Samples
shall be as set forth in the applicable Quality Agreement.

 

3.9          Product Complaints.  The Parties’ responsibilities with respect to
complaints and reports of adverse events relating to the Product in the Field in
the Licensed Territory are set forth in the Quality Agreements and the
Pharmacovigilance Agreement, respectively.

 

3.10        Recalls.  The Parties’ rights and obligations with respect to
recalls are as set forth in Section 7.4 of the License Agreement.  Additional
procedures for and consequences of recalls may be set forth in the Quality
Agreements and/or the Pharmacovigilance Agreement.

 

3.11        Waste Handling.  With respect to handling of waste related to the
Product in a Party’s control or possession (including the disposal of any
Product), such Party shall be responsible at its own cost (except as otherwise
provided in this Agreement or the License Agreement) to dispose of all such
Product and/or related waste in conformance with the applicable material safety
data sheet (“MSDS”) maintained by AMAG from time to time and all applicable
Laws.  AMAG shall provide the MSDS for Drug Substance and the MSDS for Drug
Product to Takeda promptly following the Supply Agreement Effective Date and
promptly upon any amendments thereto.

 

3.12        Spoilage; Product Yield.  AMAG shall use Commercially Reasonable
Efforts to avoid spoilage and minimize scrap loss of materials used in the
Manufacture of the Product. Except as provided below, [***], for the type of
materials and processes involved in

 

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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.

 

Manufacturing the Product by AMAG or its DSS (which shall apply to Manufacture
of the Product by AMAG or its DSS).

 

4.                                      DELIVERY AND ACCEPTANCE.

 

4.1          Delivery; Export Compliance.  For each purchase order submitted by
Takeda and accepted by AMAG in accordance with Section 2.4, AMAG shall deliver
to the common carrier specified by Takeda in the applicable purchase order the
specified quantity of Product within five (5) Days after the delivery dates
specified in the applicable purchase order.  Unless otherwise agreed by the
Parties, time is of the essence for delivery of the Product in accordance with
the delivery date(s) requested in Takeda’s purchase order.  Unless otherwise
agreed by the Parties in writing, delivery shall be made FCA (Incoterms 2010)
AMAG’s DSS’ facility or Third Party contractor’s storage warehouse set forth on
Exhibit F.  As set forth in the Quality Agreements, AMAG may change any such
facility or warehouse at which delivery may be made with six (6) months prior
written notice to Takeda, and Exhibit F will be deemed amended at the end of
such notice period (or such later date as AMAG may specify in its written
notice).  AMAG will provide Product in accordance with the terms of this
Agreement.  AMAG shall include with each shipment of Product (a) a batch
certificate, (b) a certificate of cGMP compliance, (c) a MSDS and (d) a packing
list.  At the time of each shipment, AMAG shall transmit to Takeda an electronic
copy of the foregoing documents by fax or email, as directed by Takeda.  Takeda
shall prepare, obtain, and maintain all necessary import and export licenses,
permits or registrations relating to the Product and shall keep AMAG informed
regarding the filing or maintenance of any such licenses, permits or
registrations.  Takeda shall be responsible for (x) making necessary shipping
arrangements and (y) all financial arrangements for shipping and handling of the
Product, including freight charges, storage during transit, customs, duties,
taxes, and insurance.  Title to any shipment of Product will pass to Takeda when
risk of loss passes in accordance with this Section 4.1.

 

5.                                      DELIVERY OF NON-CONFORMING PRODUCT.

 

(a)           Takeda shall notify AMAG of any shipment of Product that does not
conform to the Drug Product Specifications, the applicable Quality Agreement or
applicable Laws by giving written notice to AMAG within (i) ten (10) Business
Days after arrival of such shipment at Takeda’s delivery location at
Cerano, Italy, or other delivery location specified in the applicable purchase
order, for any nonconformity discoverable through reasonable visual inspection
of the packaging of such shipment, and (ii) the earlier of (A) the completion of
confirmatory testing of such shipment or (B) ninety (90) Days after delivery of
such shipment, for all other nonconformities, including in such notice, in each
case (i) and (ii), a description of the nature of the nonconformity
(“Non-Conformity” or “Non-Conforming”).  Takeda shall notify AMAG in writing as
promptly as reasonably practicable (but in no event later than ten (10) Business
Days after completion of confirmatory testing for such shipment.  If the
Non-Conformity under clause (ii) is latent and could not have been reasonably
discovered by Takeda during such ninety (90)-Day period (or earlier completion
of confirmatory testing) through reasonable visual inspection or the testing
procedures that Takeda is required to perform under

 

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[***] 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.

 

the applicable Quality Agreement upon receipt of such shipment, Takeda shall
notify AMAG of the Non-Conformity within fifteen (15) Days after discovery.

 

(b)           AMAG shall notify Takeda as promptly as reasonably practicable
(but in no event later than thirty (30) Days after receiving Takeda’s notice of
a Non-Conformity) whether AMAG agrees that the Product is Non-Conforming. 
Irrespective of whether AMAG agrees with Takeda’s assertion of a Non-Conformity,
AMAG shall use Commercially Reasonable Efforts to initiate manufacturing of
replacement Product for such allegedly Non-Conforming Product as soon as
reasonably practicable.

 

(c)           If AMAG agrees that the Product is Non-Conforming, then AMAG shall
replace such Non-Conforming Product as soon as reasonably practicable at no
additional cost to Takeda, and except for AMAG’s indemnification obligations
under Article 8, such replacement of the Non-Conforming Product shall be
Takeda’s sole and exclusive remedy and AMAG’s sole obligation with respect to
such Non-Conforming Product.

 

(d)           If AMAG disagrees that the Product is Non-Conforming, then such
Product shall be submitted to a mutually acceptable Third Party laboratory as
soon as reasonably practicable.  The Third Party laboratory shall determine
whether such Product is Non-Conforming, and the Parties agree that such
laboratory’s determination shall be final and determinative.  The Party against
whom the Third Party laboratory rules shall bear all costs of the Third Party
testing and all out-of-pocket costs incurred to establish and qualify the Third
Party laboratory.

 

(e)           If the Third Party laboratory determines that the Product is
Non-Conforming, then as soon as reasonably practicable, AMAG shall supply to
Takeda the Product that AMAG initiated manufacturing under sub-section
(d) above, at no additional cost to Takeda to the extent that Takeda has already
paid for such Non-Conforming Product), and except for AMAG’s indemnification
obligations under Article 8, such replacement of the Non-Conforming Product
shall be Takeda’s sole and exclusive remedy and AMAG’s sole obligation with
respect to such Non-Conforming Product.

 

(f)            If the Third Party laboratory determines that the Product is not
Non-Conforming, then Takeda shall pay AMAG for the Product manufactured under
sub-section (d) above and supplied to Takeda in accordance with Article 7, as
well as the Product initially supplied and identified by Takeda as
Non-Conforming.

 

(g)           Takeda shall, at AMAG’s expense, including shipping and handling,
freight charges, storage during transit, customs, duties, taxes, Third Party
charges for retesting for importation into Europe and insurance, return or
destroy, as directed by AMAG, any Product determined to be Non-Conforming as
provided in this Article 5.  Takeda shall perform any destruction of
Non-Conforming Product in accordance with applicable Law, and shall, upon AMAG’s
request, provide AMAG with a customary certificate of destruction attesting to
the complete destruction of the subject material and providing reasonably
sufficient information

 

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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.

 

detailing and identifying the material destroyed.  Takeda may retain a
reasonable quantity of Non-Conforming Product for its own archival purposes.

 

6.                                      SUPPLY SECURITY

 

6.1          Primary Supply Chain and Second Source.  The Parties’ obligations
with respect to the Primary Supply Chain and the establishment, regulatory
approval and maintenance of a DSS (other than the Primary Supply Chain) for each
of Drug Substance, Drug Product Intermediate and Drug Product (the “Required
Sites”) are set forth in the License Agreement.

 

6.2          Additional Designated Second Source Suppliers or Qualification
Activities.

 

(a)           In addition to the Primary Supply Chain and Required Sites, at any
time, AMAG may propose to Takeda (i) to qualify, initiate and maintain an
additional Designated Second Source Supplier or (ii) additional qualification,
initiation or maintenance activities for an existing Designated Second Source
Supplier, in each case (i) or (ii) as reasonably required to supply Product for
the Licensed Territory or to meet increased demand for Product in the Licensed
Territory.  The Parties shall promptly meet and discuss in good faith such
proposal, and shall use good faith efforts to agree on whether to conduct the
proposed activities and, if so, a detailed plan for implementing the proposal,
including the applicable activities and timelines and expenses therefor.  The
costs for implementing such proposal shall be allocated to the Parties [***],
based on Takeda’s most recent forecast volumes and AMAG’s then-current estimate
of Product volumes for [***].

 

(b)           Upon Takeda’s reasonable written request, AMAG shall use
Commercially Reasonable Efforts to qualify, initiate and maintain additional DSS
manufacturing facilities for Drug Substance, Drug Product Intermediate and/or
Drug Product, in addition to the Required Sites.  If Takeda requests any such
new DSS, Takeda shall reimburse AMAG for all costs incurred by AMAG (whether
internal costs or out-of-pocket costs, all without mark up by AMAG) to qualify,
initiate and maintain such additional DSS manufacturing facilities, provided
that Capital Equipment expenditures shall be allocated between the Parties.  If
the use of such DSS increases the Fully Burdened Manufacturing Cost to a value
that exceeds the applicable Cap, Takeda shall [***] reasonably allocated
pursuant to Section 2.6.

 

(c)           AMAG shall have the right to source Product from any DSS for
supply to Takeda at any time and for any reason, subject to Takeda’s acceptance,
not to be unreasonably withheld or delayed, and in accordance with the terms of
this Agreement.  If AMAG’s use of any such DSS (other than the Primary Supply
Chain and Required Sites) results in an increase in the Fully Burdened
Manufacturing Cost of Product, such increase will be allocated to [***], based
on Takeda’s most recent forecast volumes and AMAG’s then-current estimate of
[***].  For clarity, the Product Price for any Product obtained by AMAG from a
DSS and supplied to Takeda shall be subject to the pricing terms set forth in
Section 7.1.

 

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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.

 

6.3          Transfer Event.

 

(a)           Right to Obtain Product.  Takeda shall have the right to obtain
Product for use in the Licensed Territory directly from a DSS by placing a
purchase order through a contract to which AMAG is a party upon an Insolvency
Event of AMAG (an “Insolvency Transfer Event”).  Upon the occurrence of a
Insolvency Transfer Event, Takeda shall notify AMAG in writing of its intent to
source from the DSS and shall have the right to place a purchase order with the
DSS for that amount of Product that AMAG failed to supply based upon Takeda’s
binding purchase orders, plus any additional amount that takes into
consideration Takeda’s customer’s orders for the applicable calendar quarter and
minimum batch sizes or other minimum supply requirements imposed by a DSS.  For
clarity, Takeda’s rights under this Section 6.3(a) are limited solely to
obtaining Product from a DSS during the duration of the Insolvency Event, and
Takeda shall have no right to receive (or provide to any Third Party) any AMAG
Know-How related to Manufacturing of the Product except as otherwise expressly
provided in the License Agreement or to the extent that disclosure of AMAG
Know-How is reasonably required for Takeda to Finish the Product.  [***].

 

(b)           Cost Sharing.  If Takeda purchases Product from a DSS following an
Insolvency Transfer Event as provided in Section 6.3(a), the Parties shall
[***].  Takeda shall invoice AMAG [***] on a quarterly basis, providing
reasonable documentation therefor, and AMAG shall pay each such invoice within
thirty (30) Days after receipt thereof.

 

(c)           Purchase Resumption.  Promptly following the resolution of the
deficiency(ies) causing the Insolvency Transfer Event, Takeda shall use
Commercially Reasonable Efforts to [***]) within a reasonable time period after
AMAG: (i) reasonably demonstrates that it is able to supply Product in
accordance with the terms of this Agreement and Takeda’s most recent Commercial
Supply Forecast provided under Section 2.2 and (ii) [***] of Drug Product
exclusive to Takeda, taking into account any residual Product purchase and other
obligations of Takeda to the DSS.

 

(d)           Exclusive Remedy.  So long as AMAG (i) uses Commercially
Reasonable Efforts to meet Takeda’s forecasted demand for Product as set forth
in Takeda’s forecasts provided under Section 2.2 and (ii) uses Commercially
Reasonable Efforts to work with DSSs to supply Product to Takeda (including
using Commercially Reasonable Efforts to manage demand and supply of the
Product, taking into account the demand for Product for the Licensed Territory
and outside the Licensed Territory), Takeda’s right to place purchase orders for
Product with a DSS under Section 6.3(a) and the cost sharing provided under
Section 6.3(b) shall be Takeda’s sole and exclusive remedy, and AMAG’s sole
liability, for AMAG’s failure to supply as set forth in Sections 6.3(a);
provided, however, that the foregoing remedy shall not be the sole and exclusive
remedy if such failure to supply is caused by AMAG’s or its DSS’s (x) failure to
comply with applicable Laws relating to the Manufacture of the Product or
(y) gross negligence or willful misconduct.

 

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[***] 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.

 

(e)           Termination of Exclusive Supply.  If [***] following an Insolvency
Transfer Event, AMAG is unable to meet Takeda’s demand for Product as set forth
in Takeda’s most recent Commercial Supply Forecast provided under Section 2.2,
then Takeda shall have the right [***].  In such event, AMAG shall no longer be
obligated to supply Product to Takeda (and Takeda shall no longer be obligated
to purchase Product from AMAG), and Takeda will have the right to purchase all
of its requirements of the Product directly from a DSS.  AMAG shall reasonably
cooperate with Takeda in the transition to the DSS.  In addition, at Takeda’s
written request, AMAG shall undertake promptly, using Commercially Reasonable
Efforts, to identify, qualify and maintain one or more new DSSs reasonably
acceptable to the Parties to supply Product and Drug Substance for Product.  All
costs and expenses for such identification, qualification and maintenance shall
be allocated to Takeda and AMAG, respectively, [***], based on Takeda’s most
recent forecasts provided under Section 2.2 and AMAG’s then-current estimate of
[***].  The Parties shall use good faith efforts to agree on a reasonable
allocation of such costs and expenses.

 

7.                                      PRICES AND PAYMENT.

 

7.1          Price.  For all Product delivered to Takeda pursuant to this
Agreement, Takeda shall pay to AMAG a price per unlabeled vial determined in
accordance with this Section 7.1 (the “Product Price”), provided that such
amount shall be payable as described in Section 7.2, subject to the true-up
procedure described in Section 7.3, and subject to the remaining terms and
conditions set forth in this Article 7:

 

(a)           Initial Price Period.  For all Product ordered by Takeda [***]
period following the License Agreement Effective Date (the “Initial Price
Period”):

 

(i)            if the Fully Burdened Manufacturing Cost of Product ordered by
Takeda is [***], as set forth in Exhibit C ( as applicable [***], the “Cap”)
then the Product Price for such Product shall equal the [***]; and

 

(ii)           if the Fully Burdened Manufacturing Cost of Product ordered by
Takeda is [***], except as provided in Section 3.6.

 

(b)           Extended Price Period.  For all Product ordered by Takeda during
the [***] period following the Initial Price Period (such [***] period, the
“Extended Price Period”), the Product Price shall be calculated as described
above for the Initial Price Period, but subject to the adjustment described in
this Section 7.1(b).

 

(i)            At the end of the Initial Price Period, AMAG shall determine the
[***] used to calculate the Fully Burdened Manufacturing Cost for Product at the
beginning of each [***] after the License Agreement Effective Date ([***] , the
“Baseline Materials Cost”).  At the beginning of each [***] in the Extended
Price Period, AMAG shall determine the [***] used to calculate the Fully
Burdened Manufacturing Cost for Product ordered in such [***] (the “[***]
Materials Cost”).  If, in any such [***], the difference between the [***] and
the [***], then (A) AMAG shall determine the “Adjusted Cap” for such [***], and
(B) the

 

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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.

 

Product Price for such [***] shall be as described in Section 7.1(a), with the
Adjusted Cap substituted for the Cap.  AMAG shall notify Takeda in writing of
the Baseline Materials Cost, [***] Materials Cost and any Adjusted Cap promptly
after calculation thereof. AMAG will use the Adjusted Cap in the true-up
calculation as described in Section 7.3

 

(ii)           Notwithstanding Section 7.1(b)(i), if AMAG first supplies Product
to Takeda from a particular DSS during the [***] after the License Agreement
Effective Date (such DSS, the “New DSS”), then (A) a different Adjusted Cap
shall apply to Product supplied by the New DSS and Product supplied by AMAG or
any other DSS during the Extended Price Period, (B) the Baseline Materials Cost
and Adjusted Cap will be determined on a supplier-by-supplier basis, (C) the
Baseline Materials Cost for the New DSS will equal the [***] at the beginning of
[***] (the “Baseline Period”), and (D) the Cap will apply to the New DSS during
the Baseline Period, and the Adjusted Cap for the New DSS will be calculated at
the beginning of [***] after the Baseline Period and each [***] thereafter
during the Extended Price Period.

 

(c)           After Extended Price Period.  The Product Price for all Product
ordered by Takeda after the Extended Price Period shall equal [***].  Following
the Extended Price Period, AMAG shall use Commercially Reasonable Efforts to
reduce [***].

 

(d)           Clarifications.  To the extent reasonably practicable, the Product
Price for all Product ordered by Takeda shall be consistent with [***]. 
Notwithstanding the foregoing in Sections 7.1(a) and (b), in the event of force
majeure under Section 12.10 during the Initial Price Period or Extended Price
Period, the Product Price for Product ordered during such force majeure event
shall equal [***].

 

7.2          Method of Payment.  AMAG shall invoice Takeda for all Product
delivered hereunder during any given calendar year at a single price per vial as
described in this Section 7.2 (and a per vial Manufacturing Fee in accordance
with Section 2.6 of this Agreement).  For each calendar year, at the time of
each shipment of Product hereunder, AMAG shall provide to Takeda a written
invoice for Product supplied in such delivery with (i) a Manufacturing Fee per
vial of Product in accordance with Section 2.6 of this Agreement and (ii) the
amount payable per vial of Product being equal to the average amount per vial
that would be payable hereunder if, during the course of such calendar year,
Takeda purchased the number of vials forecast in the last Commercial Supply
Forecast for such calendar year provided by Takeda to AMAG prior to commencement
of such calendar year and the applicable price for such vials determined in
accordance with Section 7.1.  All payments due hereunder by one Party to the
other Party shall be paid in United States dollars not later than [***]
following the receipt of the applicable invoice.  Payment shall be made by wire
transfer of immediately available funds into a deposit account designated by a
Party from time to time.  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 until the date of payment at the per annum rate of [***] over the
then-current [***] or the maximum rate allowable by applicable Laws, whichever
is lower.

 

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[***] 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.

 

7.3                               Annual True-Up.

 

(a)                                 Purchase Price True-Up.  Within sixty (60)
Days after the end of each calendar year, AMAG shall provide to Takeda a report
detailing (i) the total number of vials of Product delivered by AMAG in such
calendar year, (ii) a calculation of the aggregate Purchase Price for such
Product as calculated under Section 7.1, and (iii) the actual aggregate amount
invoiced by AMAG and paid by Takeda for Product delivered in such calendar
year.  If the total amount invoiced and paid (i.e., the total amount described
in the foregoing clause (iii)) is [***] (ii)), then AMAG shall invoice and
Takeda shall pay [***] to AMAG in accordance with Section 7.2. If the total
amount invoiced and paid (i.e., the total amount described in the foregoing
clause (iii)) [***] (ii)), then AMAG shall credit [***] to the next
invoice(s) issued to Takeda under Section 7.2 for Product delivered during the
next calendar year until [***] is fully applied.  By way of an illustrative
example, [***].  Notwithstanding any other section of this Agreement, AMAG shall
have the right to off-set any credits owed by AMAG to Takeda under this
Section 7.3(a) in connection with [***] against (i) any amounts owed by Takeda
to AMAG in connection with [***] and (ii) any amounts then owed by Takeda to
AMAG against [***].

 

(b)                                 Manufacturing Fees True-Up.  Within sixty
(60) Days after the end of each calendar year, AMAG shall provide to Takeda a
report detailing (i) the [***] for Product delivered in such calendar year, and
(ii) the total amount of [***] in such calendar year in accordance with [***]. 
If the total amount invoiced and paid (i.e., the total amount described in the
foregoing clause (i)) [***] to be reimbursed by Takeda in such calendar year
(i.e., the total amount described in the foregoing clause (ii)), then AMAG shall
credit [***] to the next invoice(s) issued to Takeda under Section 7.2 for
Product delivered during the next calendar year until [***] is fully applied. 
If the total amount invoiced and paid (i.e., the total amount described in the
foregoing clause (i)) [***] to be reimbursed by Takeda in such calendar year
(i.e., the total amount described in the foregoing clause (ii)), then AMAG shall
invoice and Takeda shall pay [***] to AMAG in accordance with Section 7.2. 
Notwithstanding any other section of this Agreement, AMAG shall have the right
to off-set any credits owed by AMAG to Takeda under this Section 7.3(b) in
connection with the [***] against (i) any amounts owed by Takeda to AMAG in
connection with the [***] and (ii) any amounts then owed by Takeda to AMAG
against the aggregate of Capital Equipment expenditures to be reimbursed by
Takeda that were incurred by AMAG in that particular calendar year or the prior
calendar year.

 

7.4                               Taxes.  The Parties will cooperate and use
commercially reasonable efforts to minimize the imposition of value added,
sales, excise, and other taxes and government charges on the sale and delivery
of Product purchased by Takeda.  Takeda will be responsible for payment of any
and all taxes (other than taxes based upon the income of AMAG) (including
applicable value added, sales, use or similar consumption taxes imposed, and for
any customs or import duties, tariffs or taxes imposed as a result of the
purchase, sale, use, importation or delivery destination of Product as specified
by Takeda.  In the event that any payment made under this Agreement is subject
to a deduction and withholding of any tax, [***].  Takeda shall timely pay over
to the appropriate tax authority for the account of AMAG, the amount of tax
deducted and withheld from the payment made to AMAG. Takeda will promptly
provide AMAG

 

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[***] 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.

 

with an original receipt or other documentation satisfactory to AMAG evidencing
payment of the tax to the tax authority.  Takeda and AMAG will reasonably
cooperate in completing and filing documents required under the provisions of
any applicable tax treaty or under any other applicable Laws, in order to enable
Takeda to reduce or eliminate the amount of any tax that must be deducted and
withheld from any payment made to AMAG under this Agreement.  In the event AMAG
recovers any tax amounts previously deducted or withheld, all such tax amounts
that are recovered by AMAG (net of any out-of-pocket expenses paid by AMAG to
recover such tax amounts) shall be promptly paid by AMAG to Takeda.

 

7.5                               Records; Audits.  AMAG shall maintain complete
and accurate records in sufficient detail to permit Takeda to confirm the
accuracy of the Fully Burdened Manufacturing Costs, Baseline Materials Cost and
[***] Materials Cost under this Agreement and to verify AMAG’s compliance with
Sections 2.1, 3.12 and 7.1(d), and Takeda shall maintain complete and accurate
records in sufficient detail to permit AMAG to confirm the accuracy of any
amounts paid to Takeda under Section 6.3(b) and to confirm Takeda’s compliance
with its obligations under Section 2.2 to provide a Commercial Supply Forecast
that is reasonably consistent with its projected commercial sales of the Product
on a quarterly basis.  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, not more often than once each
Fiscal Year, by an independent certified public accountant selected by the other
Party and reasonably acceptable to the audited Party, for the sole purpose of
verifying the accuracy of such amounts invoiced, AMAG’s compliance with Sections
2.1, 3.12 and 7.1(d), and Takeda’s compliance with Section 2.2.  Any such
auditor shall not disclose the audited Party’s Confidential Information, except
to the extent such disclosure is necessary to verify the accuracy of the
invoices issued by such Party or the amount of payments due by a Party under
this Agreement, confirm AMAG’s compliance with Sections 2.1, 3.12 and 7.1(d) or
confirm Takeda’s compliance with Section 2.2. Any amounts shown to be owed but
unpaid (and not otherwise the subject of a good faith dispute by a Party) shall
be paid within [***] from the accountant’s report, plus interest (as set forth
in Section 7.2) from the original due date.  Any amounts showed to have been
overpaid (and not otherwise the subject of a good faith dispute by a Party) will
be refunded within [***] from the accountant’s report.  The auditing Party shall
bear the full cost of such audit involving payments of amounts owed hereunder
unless such audit discloses an overpayment by the auditing Party or underpayment
by the audited Party during the applicable Fiscal Year of more than [***] of the
amount due, in which case the audited Party shall bear the full cost of such
audit.

 

7.6                               Harmonization.

 

(a)                                 [***]

 

(b)                                 [***]

 

(c)                                  [***]

 

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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)                                 [***]

 

8.                                      REPRESENTATIONS AND WARRANTIES

 

8.1                               Mutual Representations and Warranties.  Each
Party hereby represents and warrants to the other Party as of the Supply
Agreement Effective Date as follows:

 

(a)                                 Such Party (i) is duly organized, validly
existing and in good standing under the laws of the state in which it is
organized; (ii) has the power and authority and the legal right to own and
operate its property and assets, to lease the property and assets it operates
under lease, and to carry on its business as it is now being conducted; and
(iii) is in compliance with all requirements of applicable law, except to the
extent that any noncompliance would not materially adversely affect such Party’s
ability to perform its obligations under this Agreement.

 

(b)                                 Such Party (i) has the power and authority
and the legal right to enter into this Agreement and to perform its obligations
hereunder and (ii) has taken all necessary action on its part to authorize the
execution and delivery of this Agreement and the performance of its obligations
hereunder.  This Agreement has been duly executed and delivered on behalf of
such Party, and constitutes a legal, valid, binding obligation, enforceable
against such Party in accordance with its terms, except as such enforcement may
be affected by bankruptcy, reorganization, insolvency, moratorium or similar
laws affecting creditor’s rights generally and except for general principles of
equity.

 

(c)                                  All necessary consents, approvals and
authorizations of all governmental authorities and other persons required to be
obtained by such Party in connection with this Agreement have been obtained,
except for those that cannot be obtained prior to the filing or approval of a
Marketing Authorization Application for the Product.

 

(d)                                 The execution and delivery of this Agreement
and the performance of such Party’s obligations hereunder (i) do not conflict
with or violate any requirement of applicable Laws or any material contractual
obligation of such Party and (ii) do not materially conflict with, or constitute
a material default or require any consent under, any material contractual
obligation of such Party.

 

8.2                               No Debarment.  In the course of Manufacturing
the Product, each Party shall not use, during the term of this Agreement any
employee, contractor or consultant who has been debarred by any Regulatory
Authority, or, to such Party’s Best Knowledge, is the subject of debarment
proceedings by a Regulatory Authority. Each Party shall notify the other Party
promptly upon becoming aware of any employee, contractor or consultant who has
been debarred or is the subject of debarment proceedings by any Regulatory
Authority.

 

8.3                               Limited Warranty.  AMAG warrants that Product
at the time of delivery to Takeda will: (i) be manufactured, tested and released
in accordance with the Specification as set forth in the applicable Quality
Agreement, cGMP, applicable Laws and the applicable Quality Agreement, (ii) not
be adulterated or misbranded within the meaning of the FD&C Act or other

 

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[***] 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.

 

applicable Laws, (iii) conforms to the applicable Drug Product Specifications,
and (iv) be delivered not later than six (6) months from the date of manufacture
of such Product; provided that (A) Interim Product are known to have a
manufacturing date of as set forth on Exhibit A (and Section 8.3(iv) shall not
apply to such Interim Product), and (B) in the event of a quality investigation
of any Product, such Product will be delivered not later than eight (8) months
from the date of manufacture of such Product unless otherwise agreed to by the
Parties in writing.

 

8.4                               Warranty Disclaimer.  EXCEPT AS EXPRESSLY
PROVIDED IN THE LICENSE AGREEMENT AND THIS AGREEMENT, NO REPRESENTATIONS OR
WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR
NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, ARE MADE OR
GIVEN BY OR ON BEHALF OF A PARTY.

 

9.                                      INDEMNIFICATION; LIMITATION OF
LIABILITY.

 

9.1                               Indemnity.  In addition to the Parties’
indemnification rights and obligations under Article 11 of the License Agreement
for activities other than the Manufacture of Product, the Parties’ shall have
the following rights and obligations:

 

(a)                                 Indemnification by AMAG.  AMAG shall defend,
indemnify, and hold Takeda and its Affiliates and their respective officers,
directors, employees, and agents (the “Takeda 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, “Claims”) to the extent that such Claims arise out of,
are based on, or result from: (i) AMAG’s or its Affiliates’ or DSS’ willful
misconduct or gross negligence with respect to the Manufacture of Product; or
(ii) AMAG’s breach of its obligations, warranties, representations or covenants
under this Agreement.  The foregoing indemnity obligation shall not apply to the
extent (x) that the Takeda Indemnitees fail to comply with the indemnification
procedures set forth in Section 9.1(c) and AMAG’s defense of the relevant Claims
is materially prejudiced by such failure, or (y) of any Claim for which Takeda
is required to indemnify any AMAG Indemnitee under this Agreement or the License
Agreement.

 

(b)                                 Indemnification by Takeda.  Takeda shall
defend, indemnify, and hold AMAG and its Affiliates and its DSS and their
respective officers, directors, employees, and agents (the “AMAG Indemnitees”)
from and against any and all Claims to the extent that such Claims arise out of,
are based on, or result from: (i) Takeda’s or its Affiliates’ or contract
manufacturers’ Manufacture of Product; or (ii) Takeda’s breach of its
obligations, warranties, representations or covenants under this Agreement.  The
foregoing indemnity obligation shall not apply to the extent (x) that the AMAG
Indemnitees fail to comply with the indemnification procedures set forth in
Section 9.1(c) and Takeda’s defense of the relevant Claims is materially
prejudiced by such failure, or (y) of any Claim for which AMAG is required to
indemnify any Takeda Indemnitee under this Agreement or the License Agreement.

 

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[***] 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)                                  Indemnification Procedures.  The Party
claiming indemnity under this Section 9.1 (the “Indemnified Party”) shall give
written notice to the Party from whom indemnity is being sought (the
“Indemnifying Party”) in a reasonably timely manner 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, however, 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 or
delayed, unless the settlement involves only the payment of money.  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, (i) 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 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 (ii) the Indemnifying Party will remain responsible to indemnify
the Indemnified Party as provided in this Section 9.1.

 

9.2                               Limitation of Liability.  NEITHER PARTY WILL
BE LIABLE TO THE OTHER PARTY 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 9.2 IS INTENDED TO LIMIT
OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF THE PARTIES UNDER THIS
ARTICLE 9 OR UNDER ARTICLE 11 OF THE LICENSE AGREEMENT, OR DAMAGES AVAILABLE FOR
A PARTY’S BREACH OF CONFIDENTIALITY OBLIGATIONS IN ARTICLE 10 OR UNDER
ARTICLE 12 OF THE LICENSE AGREEMENT.

 

10.                               CONFIDENTIALITY.

 

10.1                        Confidentiality.  The Parties agree that any
Confidential Information (as defined in the License Agreement) of a Party
disclosed by such Party to the other Party under this Agreement shall be deemed
to have been disclosed under the License Agreement and shall be subject to all
the rights and obligations of the Parties under the provisions of Article 12
and, if applicable, Section 5.1(b), of the License Agreement.  For clarity,
Takeda agrees and acknowledges that the Specifications and the Acceptance Tests
are the Confidential Information of AMAG.

 

11.                               TERM AND TERMINATION.

 

11.1                        Term.  This Agreement shall commence on the Supply
Agreement Effective Date and shall continue in effect until the expiration or
termination of the License Agreement.

 

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[***] 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.

 

11.2                        Surviving Obligations.  Termination or expiration of
this Agreement shall not (a) affect any other rights of either Party that may
have accrued up to the date of such termination or expiration or (b) relieve
Takeda of its obligation to pay to AMAG sums due in respect of firm orders of
Product submitted prior to termination or expiration of this Agreement.  The
provisions of ARTICLES 5, 9, 10 and 12 and Sections 3.8, 7.5, 8.4 and 11.2 shall
survive the termination or expiration of this Agreement.

 

12.                               GENERAL TERMS.

 

12.1                        Dispute Resolution.  Except as expressly provided in
Section 5(c) of this Agreement and subject to Sections 14.5 and 14.6 of the
License Agreement, any dispute between the Parties arising out or relating to
this Agreement or any Quality Agreement that the Parties are unable to resolve
within [***] after such dispute is first identified by either Party in writing
to the other, shall be referred by the Parties to the Designated Executive for
each Party for attempted resolution by good faith negotiations within [***]
after such notice is received.  If any such dispute is not resolved by such
Designated Executives within such period, either Party may at any time
thereafter invoke the ADR provisions set forth in Exhibit E to the License
Agreement.

 

12.2                        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.

 

12.3                        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,
United States of America, without giving effect to any choice of law principles
that would require the application of the laws of a different state.  The UN
Convention on Contracts for the International Sale of Goods is expressly
disclaimed.

 

12.4                        Notice.  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 12.4, and shall be deemed to have been
given for all purposes (a) when received, if hand-delivered or sent by a
reputable courier service, or (b) five (5) business Days after mailing, if
mailed by first class certified or registered airmail, postage prepaid, return
receipt requested.

 

If to AMAG:

 

AMAG Pharmaceuticals, Inc.

 

 

1100 Winter Street

 

 

Waltham, MA 02451

 

27

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[***] 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.

 

 

 

USA

 

 

Attn: General Counsel

 

 

 

 

 

AMAG Pharmaceuticals, Inc.

 

 

1100 Winter Street

 

 

Waltham, MA 02451

 

 

USA

 

 

Attn: Chief Business Officer

 

 

 

With a copy to:

 

Goodwin Procter LLP

 

 

Exchange Place

 

 

53 State Street

 

 

Boston, MA 02109

 

 

USA

 

 

Attn: Stuart Cable, Esq.

 

 

 

If to Takeda:

 

Takeda Pharmaceuticals International GmbH

 

 

Thurgauerstrasse 130

 

 

CH-8152 Glattpark-Opfikon (Zurich)

 

 

 

 

 

Takeda Pharma A/S

 

 

Langebjerg 1

 

 

4000 Roskilde

 

 

Denmark

 

 

Attn: Operations External Supply

 

 

 

 

 

Takeda Pharmaceuticals International GmbH

 

 

Corporate Legal

 

 

Thurgauerstrasse 130

 

 

CH-8152 Glattpark-Opfikon

 

 

Switzerland

 

 

Attn: General Counsel

 

12.5                        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.

 

12.6                        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

 

28

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[***] 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.

 

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.

 

12.7                        Entire Agreement.  This Agreement and the exhibits
attached hereto, along with the License Agreement and the Letter Agreement,
constitute the entire, final, complete and exclusive agreement between the
Parties and supersede all previous agreements or representations, written or
oral, with respect to the subject matter of this Agreement, including the
Interim Agreements, which are hereby terminated in accordance with their terms. 
This Agreement may not be modified or amended except in a writing signed by a
duly authorized representative of each Party.

 

12.8                        Nonassignability; Binding on Successors.  Neither
Party may assign or transfer this Agreement or any rights or obligations
hereunder without the prior written consent of the other, except that a Party
may make such an assignment without the other Party’s consent to its Affiliates
or to a Third Party successor to substantially all of the business of such Party
in connection with a Change of Control of such Party under which the License
Agreement is assigned or transferred to such Third Party.  Any successor or
assignee of rights and/or obligations permitted hereunder shall, in writing to
the other Party, expressly assume performance of such rights and/or
obligations.  Any permitted assignment shall be binding on the successors of the
assigning Party.  Any assignment or attempted assignment by either Party in
violation of the terms of this Section 12.8 shall be null, void and of no legal
effect.

 

12.9                        Performance by Affiliates.  Each Party may discharge
any obligations and exercise any right hereunder through any of its Affiliates,
including, in the case of TPC, Takeda.  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 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. The Parties
agree and acknowledge the confirmation of TPC with respect to such obligation in
the Letter Agreement.

 

12.10                 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 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

 

29

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

 

[***] 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.

 

circumstances). If a force majeure persists for more than [***], then the
Parties will discuss in good faith the modification of the Parties’ obligations
under this Agreement in order to mitigate the delays caused by such force
majeure.

 

12.11                 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.

 

[Signature page follows]

 

30

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

 

[***] 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.

 

SIGNATURE PAGE TO SUPPLY AGREEMENT

 

IN WITNESS WHEREOF, each Party has caused this Supply Agreement to be signed and
delivered by its duly authorized officer or representative as of the Supply
Agreement Effective Date.

 

 

AMAG PHARMACEUTICALS, INC.

 

 

 

 

 

By:

/s/ William K. Heiden

 

 

 

 

Name: William K. Heiden

 

 

 

Title: President and Chief Executive Officer

 

 

 

Date:  2/7/14

 

 

 

TAKEDA PHARMACEUTICALS INTERNATIONAL GMBH

 

 

 

 

By:

/s/ Dr. Barthold Piening

 

 

 

Name: Dr. Barthold Piening

 

 

 

Title: Executive Vice President Operations

 

 

 

 

 

By:

/s/ Alexander Maechler

 

 

 

Name: Alexander Maechler

 

 

 

Title: Senior Director Corp. Legal

 

 

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

 

[***] 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.

 

EXHIBIT A

INTERIM PRODUCT BATCHES

 

Region

 

Lot #

 

Lot Size

 

Mfg date
Mon/YR

 

AMAG Release
Status

 

Vials with Takeda

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

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

 

[***] 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.

 

EXHIBIT B

COMMERCIAL SUPPLY FORECASTING

 

[***]

 

C-1

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

 

[***] 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.

 

EXHIBIT C

PRODUCT PRICE DURING INITIAL PRICE PERIOD

 

[***]

 

[***]

[***]

 

[***]

[***]

 

[***]

[***]

 

[***]

[***]

 

[***]

 

D-1

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

 

[***] 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.

 

EXHIBIT D

 

MINIMUM ORDER QUANTITY

 

Regulatory Jurisdiction

 

Minimum Order Quantity

 

Canada

 

Switzerland

 

European Union

 

 

[***]

All other countries and
regions of the Licensed
Territory

 

[***], unless agreed otherwise

by the Parties in writing

 

E-1

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

 

[***] 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.

 

EXHIBIT E

 

CAPITAL EQUIPMENT EXPENDITURES

 

[***]

 

F-1

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

 

[***] 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.

 

EXHIBIT F

 

LOCATIONS OF DSS AND THIRD PARTY CONTRACTOR WAREHOUSE

 

DSS and Third Party Contractor
Warehouse

 

Locations

Drug Substance & Drug Product Intermediate

 

SAFC

3300 South Second St.

Saint Louis, MO 63118

USA

 

 

 

Drug Product

 

DSM

5900 Martin Luther King Jr. Hwy

Greenville, NC 27834

USA

 

 

 

Third Party Warehouse

 

PACKAGING COORDINATOR’S INC.

(successor in interest to Catalent Pharma Solutions)

3001 Red Lion Road

Philadelphia, PA 19114

USA

 

PACKAGING COORDINATOR’S INC.

(successor in interest to Catalent Pharma Solutions)

2200 Lake Shore Drive

Woodstock, IL, 60098

USA

 

G-1

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