Exhibit 10.2

 

Execution Version

 

COMMERCIAL PACKAGING SERVICES AGREEMENT

 

(ferumoxytol IV)

 

This Agreement is made as of this 29th day of May 2009 (“Effective Date”), by
and between AMAG Pharmaceuticals, Inc., a Delaware corporation with a place of
business at 100 Hayden Avenue, Lexington, MA 02421 (“AMAG”) and Catalent Pharma
Solutions, LLC, a Delaware limited liability company, by and through its
Packaging Services group with an office at 3001 Red Lion Road, Philadelphia,
Pennsylvania (“Catalent”).

 

RECITALS

 

A.                                    Catalent provides packaging and related
services to the pharmaceutical industry; and

 

B.                                    AMAG is a pharmaceutical company that
manufactures, markets, and sells pharmaceutical products; and

 

C.                                    AMAG desires to engage Catalent to provide
certain services to AMAG in connection with the packaging of AMAG’s Product (as
defined below) and Catalent desires to provide such services pursuant to the
terms and conditions set forth in this Agreement.

 

THEREFORE, in consideration of the mutual covenants, terms and conditions set
forth below, the parties agree as follows:

 

ARTICLE 1
DEFINITIONS

 

The following terms have the following meanings in this Agreement:

 

1.1                               “Affiliate(s)” means, with respect to AMAG or
any third party, any corporation, firm, partnership or other entity that
controls, is controlled by or is under common control with such entity; and with
respect to Catalent, any corporation, firm, partnership or other entity
controlled, directly or indirectly, by Catalent Pharma Solutions, Inc.  For
purposes of this definition, “control” shall mean the ownership of at least 50%
of the voting share capital of entity or any other comparable equity or
ownership interest.

 

1.2                               “AMAG-Supplied Materials” means any Product,
active pharmaceutical ingredient, bulk drug, drug in primary packaging or other
components to be supplied by AMAG to Catalent for Catalent’s provision of the
Packaging.

 

1.3                               “Applicable Laws” means all laws, ordinances,
rules and regulations within the Territory applicable to the Packaging of the
Product or any aspect thereof and the obligations of Catalent or AMAG, as the
context requires under this Agreement, including, without limitation, (A) all
applicable federal, state and local laws and regulations of each Territory,
(B) the U.S.

 

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Federal Food, Drug and Cosmetic Act, and (C) the Good Manufacturing Practices
(“GMPs”) promulgated by the Regulatory Authorities, as amended from time to
time, as applicable to the Packaging.

 

1.4                               “Batch” means a specific quantity of a Product
or Packaged Product, as applicable, comprising a number of units of Product or
Packaged Product, as applicable, mutually agreed upon by the parties in writing
that (i) is intended to have uniform character and quality within specified
limits, and (ii) is processed according to the master batch record during the
same cycle of production.

 

1.5                               “Confidential Information” has the meaning set
forth in Section 9.2.

 

1.6                               “Contract Year” means the twelve (12) month
period commencing on the Effective Date and successive twelve (12) month periods
commencing on the anniversary(ies) of the Effective Date during the term of this
Agreement.

 

1.7                               “Delivery Date” means the date set forth in
the relevant Purchase Order on which Catalent must supply AMAG with Packaged
Products, when accepted by Catalent pursuant to Section 4.3.

 

1.8                               “Facility” means Catalent’s facility at 3001
Red Lion Road, Philadelphia, Pennsylvania, or such other facilities as agreed
upon in writing by the parties.

 

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

 

1.10                        “Package(d)/Packaging” means the packaging of the
Product pursuant to the Specifications.

 

1.11                        “Packaged Product” means the Product once Packaged.

 

1.12                        “Product(s)” means certain ferumoxytol products to
be supplied by AMAG in vials, which are more fully described in the
Specifications.

 

1.13                        “Purchase Order” means a written document issued by
AMAG to Catalent in accordance with Article 4 hereof, authorizing Catalent’s
performance of Packaging and other related services pursuant to the terms of
this Agreement.

 

1.14                        “Regulatory Authority” means any governmental
regulatory authority within a Territory involved in regulating any aspect of the
development, manufacture, market approval, sale, distribution, packaging or use
of the Product.

 

1.15                        “Specifications” means the specifications for the
Packaging set forth in Exhibit A attached to and incorporated in this Agreement,
which shall become a part of this Agreement.

 

1.16                        “Territory” means the United States of America and
any other country which the parties agree to add to this definition of Territory
in an amendment to this Agreement.

 

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ARTICLE 2
SCOPE

 

2.1                               Catalent agrees to Package the Product at the
Facility and AMAG agrees to purchase and pay for the Packaging, in each case in
accordance with the terms and conditions set forth in this Agreement.

 

ARTICLE 3
PRICING AND PAYMENT TERMS

 

3.1                               Price.  The fees to be paid to Catalent for
the Packaging of the Product shall be as set forth in Exhibit B attached to and
incorporated in this Agreement (“Price”).

 

3.2                               Price Adjustment.  The Price is subject to
adjustment [***], effective [***], upon thirty (30) days written notice from
Catalent to AMAG.  All price increases for raw materials, labor, utilities and
components shall be passed through to AMAG.  Upon request, Catalent shall
provide reasonable supporting documentation for such increases.  However, no
such increase will exceed [***] since the last such adjustment.

 

3.3                               Payment.  Catalent shall invoice AMAG upon
completion of Packaging and AMAG shall make full payment for Packaged Product
tendered for delivery in accordance with Section 3.6 (except for amounts subject
to any bona fide dispute) in US dollars via wire transfer to Catalent, no later
than thirty (30) days from the date of such invoice.  If AMAG has not made
payment in full of any undisputed amounts by the expiration of such thirty (30)
day period, Catalent may, at its option elect to: (i) charge a late payment fee
on such unpaid amount equal to one and a half percent (1.5%) per month of such
unpaid amount; or (ii) suspend any further deliveries hereunder until such
invoice is paid in full.

 

3.4                               Advance Payment.  If at any time, AMAG failed
to make timely payment in full of all undisputed amounts for two (2) consecutive
invoices, Catalent shall have the right to require payment in advance before
making any further shipment of the Packaged Products.  If AMAG shall fail,
within a reasonable time, to make such payment in advance, or if AMAG shall fail
to make payment when due, Catalent shall have the right, at its option, to
suspend any further deliveries hereunder until such default is corrected,
without thereby releasing AMAG from its payment obligations under this
Agreement.

 

3.5                               Taxes.  Any tax (other than Catalent’s income
or franchise taxes), however denominated and measured, imposed upon the Product
or upon its manufacture, Packaging, production, storage, inventory, sale,
distribution, transportation, delivery, use or consumption and on any AMAG owned
tooling and equipment are the responsibility of AMAG, and AMAG shall reimburse
Catalent for any such taxes, duties or other expenses paid by Catalent and for
which documentation is provided to 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.

 

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3.6                               Deliveries; Shipping.  AMAG will be solely
responsible for ensuring that all Product and AMAG-Supplied Materials are
delivered to Catalent’s Facility in a timely manner by a carrier obtained by
AMAG.  All Packaged Product shall be delivered by Catalent to AMAG FCA
(Incoterms 2000) the Facility and Catalent will use reasonable efforts to
cooperate with the delivery of Product to AMAG, its designee or common carrier. 
The common carrier shall be selected by AMAG, and title and risk of loss of the
Packaged Product shall pass to AMAG upon delivery by Catalent FCA (Incoterms
2000) at the Facility.  Catalent will provide AMAG with a copy of the batch
record for each Batch of Packaged Product delivered under this Agreement.

 

3.7                               Failure to Take Delivery.  If AMAG fails to
take delivery of an order of Packaged Product on the scheduled Delivery Date,
then Catalent will store such quantities of Packaged Product in accordance with
AMAG’s written instructions and will bill AMAG on the first of each month
thereafter for reasonable administration and storage costs for such quantities
at Catalent’s then-current, standard rates.  For any such quantity of
undelivered Packaged Product, AMAG agrees that: (A) AMAG has made a fixed
commitment to purchase such Packaging and Packaging components, (B) risk of
ownership for such Packaged Product shall be borne by AMAG, (C) such Packaged
Product shall be on a bill and hold basis for legitimate business purposes;
(D) if no delivery date is determined at the time of billing, Catalent shall
have the right to ship the Packaged Product to AMAG within two (2) months after
billing, and (E) AMAG shall be responsible for any decrease in market value of
such Packaged Product that relates to factors and circumstances outside of
Catalent’s control.  Within five (5) days following a written request from
Catalent, AMAG shall provide Catalent with a letter confirming items (A) through
(E) of this Section for each Batch of undelivered Packaged Product.

 

ARTICLE 4
FORECAST, PURCHASE AND SUPPLY

 

4.1                               Purchase and Supply.  During the term of this
Agreement and subject to Section 4.4 of this Article 4, AMAG shall purchase and
Catalent shall supply such quantities of Packaged Product as shall be set forth
on Purchase Orders issued by AMAG to Catalent under this Agreement.

 

4.2                               Forecasts.  Not later than ten (10) days after
the receipt of market approval for a Product to be packaged hereunder, and
thereafter on the first day of each calendar month during the term of this
Agreement, AMAG shall provide Catalent with a written twelve (12) month rolling
forecast (commencing with the immediately following month) of the quantity of
Packaged Product which AMAG expects to require from Catalent during each of the
next twelve (12) months (“Forecast”).  The first three (3) months of the
Forecast shall be firm and binding upon the parties (“Firm Commitment”), and the
following nine (9) months shall constitute non-binding good faith estimates. 
Each Forecast shall include (i) the requested Delivery Dates for the Packaged
Product within the Firm Commitment, (ii) the quantity of Packaged Product to be
delivered and (iii) the lot numbers to be applied to such Packaged Product.

 

4.3                               Purchase Order.  AMAG shall submit Purchase
Orders for the Firm Commitment at least sixty (60) days prior to the requested
Delivery Date.  Purchase Order quantities may be requested, which are not
equivalent to the Batch sizes specified in Exhibit B, but will be subject to
batch change over charges as specified in Exhibit B.  Within ten (10) days

 

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of receipt of a Purchase Order, Catalent shall confirm acceptance of such
Purchase Order in writing.  Catalent may not reject any Purchase Order that does
not (i) exceed the then-current Firm-Commitment, (ii) materially shorten the
delivery or performance schedule for Packaging, or (iii) materially alter the
Specifications or Packaging, and may not unreasonably reject any other Purchase
Order.  Catalent’s confirmation shall, as applicable, also confirm the Delivery
Date or specify alternate Delivery Dates.

 

4.4                               Orders Greater than Forecast.  Catalent shall
use its commercially reasonable efforts within its existing capacity to supply
the quantity of Packaged Product ordered as set forth on the relevant Purchase
Order, regardless of the quantity forecast by AMAG subject to the capacity
limitations of Catalent’s Packaging equipment and the Facility.

 

4.5                               Amendment of Purchase Orders.  Catalent shall
use commercially reasonable efforts to accommodate a request by AMAG to amend a
Purchase Order to increase or decrease the quantity of Packaged Product to be
delivered, provided, however, that the foregoing shall not affect or diminish
AMAG’s liability under the Firm Commitment.  In the event such amendment causes
an increase in Catalent’s cost to perform the Packaging, the Price shall be
increased to reflect such increased cost.  Catalent shall notify AMAG of such
cost increase promptly after Catalent’s receipt from AMAG of the amended
Purchase Order, and the increase in such prices shall be effective for the first
lot of Product Packaged after the implementation date of such amendment.

 

4.6                               Terms of Agreement Govern.  No modification or
amendment to this Agreement shall be effected by or result from the receipt,
acceptance, signing or acknowledgement of any party’s purchase orders, Catalent
quotations, invoices, shipping documents or other business forms containing
terms or conditions in addition to or different from the terms and conditions
set forth in this Agreement, including but not limited to the payment and
shipping terms.  The terms of this Agreement shall supersede any provision in
any Purchase Order or other document that is in addition to or inconsistent with
the terms of this Agreement.

 

4.7                               Changes to Specifications.  Should AMAG desire
to change the Specifications, AMAG may propose a written amendment to this
Agreement reflecting the desired changes.  In such case, Catalent will provide
AMAG with any proposed changes in the price or the timing of Packaging
occasioned by the change in the Specifications.  Such amendment will be binding
on the parties only if approved by both parties in writing, and will reflect any
such changes in the price or the timing of Packaging.

 

ARTICLE 5
MATERIALS

 

5.1                               Supply of Product.  AMAG shall supply to
Catalent in accordance with Section 3.6 the Product in quantities sufficient to
meet the requirements set forth in accepted Purchase Orders no later than
fifteen (15) days before the scheduled Packaging date.  Catalent shall use the
Product solely and exclusively for Packaging under this Agreement.

 

5.2                               Packaging Components.  Catalent shall be
responsible for procuring, inspecting and releasing adequate Packaging
components as necessary to meet Purchase Orders submitted

 

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by AMAG hereunder, unless otherwise agreed to by the parties in writing.  In
certain instances, AMAG may require a specific supplier to be used for Packaging
components.  In such event, the supplier shall be specified in the
Specifications, and AMAG shall be responsible for the timeliness, quantity and
quality of supply of such Packaging components.

 

5.3                               Reimbursement for Materials.  In the event of
(A) a Specification change for any reason, (B) termination or expiration of this
Agreement, or (C) obsolescence of any Packaging component, AMAG shall bear the
cost of any unused Packaging components, plus a markup equal to [***] of
Catalent’s [***] cost of such Packaging components for waste, material handling
and administration fees, provided that Catalent purchased such Packaging
components in quantities consistent with AMAG’s most recent Firm Commitment.

 

ARTICLE 6
REGULATORY

 

6.1                               Regulatory Authority Inspection.  Catalent
hereby agrees to advise AMAG promptly of any proposed or unannounced inspection
of the Product(s), Packaged Products or Packaging process or procedures by any
Regulatory Authority and shall, promptly provide a report of the results of the
inspection to AMAG.

 

6.2                               AMAG Technical Representative.  During the
term of this Agreement, AMAG shall have the right to have one or more technical
representatives present in the area of the Facility where the Packaging is being
conducted during the Packaging process to (i) review the Packaging process;
(ii) review any relevant records in connection with such Packaging process and
assess its compliance with cGMP and the Specifications; and (iii) discuss any
related issues with Catalent’s management personnel.  AMAG’s technical
representatives, when on-site (including during any inspection conducted
pursuant to Section 6.1), shall comply with Catalent’s rules and regulations.

 

6.3                               Audit; Reporting.  AMAG shall have the right
during normal business hours, and upon at least ten (10) business days written
notice to Catalent, to inspect and audit in a reasonable manner those portions
of the Facility in which Packaging is conducted in order to ensure Catalent’s
compliance with its obligations under this Agreement.  Not later than three
(3) business days following the end of each calendar month, Catalent shall
deliver to AMAG a written report (or provide AMAG with automated access to such
information) in a form and manner reasonably acceptable to the parties,
detailing shipping and inventory information for the AMAG Supplied Materials and
the Packaged Product to include a summary of inventory held by Catalent as of
the close of such calendar month, shipments received and made by Catalent during
such month and any Packaged Product held by Catalent on a “bill and hold” basis.

 

6.4                               Product Information.  AMAG, at its expense,
shall furnish Catalent with all available health, safety and environmental
information concerning the Product to be Packaged by Catalent hereunder,
including without limitation, material safety data sheets.

 

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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.

 

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6.5                               Product Loss.  Catalent shall store, handle
and use the Product and other AMAG Supplied Materials in accordance with this
Agreement and the terms of the Quality Agreement and shall use commercially
reasonable efforts to minimize waste and loss of the Product and AMAG-Supplied
Materials in the Packaging.  Subject to the foregoing, Catalent will not be
liable for any defects in or losses of Packaged Product in each case to the
extent caused by any Product or AMAG-Supplied Materials.  Notwithstanding,
Catalent and AMAG agree that Catalent may experience certain ordinary and normal
manufacturing losses of AMAG-Supplied Materials, Product or Packaged Product in
Packaging the Product in accordance with the terms of this Agreement in an
amount not to exceed [***] of the total Product Packaged during a Contract Year
(the “Acceptable Manufacturing Loss”).  Catalent shall provide AMAG with a
written report of any Acceptable Manufacturing Loss incurred in connection with
the Packaging of each Batch promptly following the delivery of such Batch.  AMAG
acknowledges that Catalent may reduce the quantity of Packaged Product in a
Batch to be delivered pursuant to a Purchase Order issued under this Agreement
to the extent of any Acceptable Manufacturing Loss actually incurred for such
Batch and to the extent such reduction does not exceed the Acceptable
Manufacturing Loss for Batches then-Packaged, and that such reduction will not
be a breach of Section 4.1 of this Agreement.  Subject to the limitation of
Article 12 and any amounts within the Acceptable Manufacturing Loss, Catalent
also shall be responsible for the Replacement Cost (as defined in Exhibit D) of
Product and AMAG-Supplied Materials to the extent of any damage, loss, theft or
destruction while on Catalent’s premises, and not later than thirty (30) days
following the end of each Contract Year, Catalent shall provide AMAG with a
detailed accounting of any Acceptable Manufacturing Loss actually incurred
during such Contract Year together with a payment representing the Replacement
Cost for the losses of Product or AMAG-Supplied Materials, if any, that in the
aggregate exceed the Acceptable Manufacturing Loss for such Contract Year (any
such payment under this Section 6.5, a “Product Loss Payment”).

 

6.6                               Regulatory Compliance.  AMAG shall be solely
responsible for all permits and licenses required by any Regulatory Authority
with respect to the Product and the Packaging under this Agreement, including
any product licenses, applications and amendments in connection therewith. 
Catalent shall be responsible to maintain all permits and licenses required by
any Regulatory Authority with respect to the Facility.  The parties shall enter
into a Quality Agreement in the form attached hereto as Exhibit C
contemporaneously with this Agreement.  In the event of a conflict between any
of the provisions of this Agreement and the Quality Agreement with respect to
quality-related activities, including compliance with cGMP, the provisions of
the Quality Agreement shall govern.  In the event of a conflict between any of
the provisions of this Agreement and the Quality Agreement with respect to any
commercial matters, including but not limited to allocation of risk, liability
and financial responsibility, the provisions of this Agreement shall govern. 
During the term, Catalent shall assist AMAG with all regulatory matters relating
to Packaging under this Agreement, at AMAG’s request and at AMAG’s expense. 
Each party intends and shall cooperate to satisfy all Applicable Laws relating
to Packaging under this 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.

 

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ARTICLE 7
TESTING; SAMPLES

 

7.1                               Sampling and Testing of Packaged Products. 
AMAG is responsible for all sampling and testing of the Packaged Products to
assure that the Packaged Products are in conformity in all material respects
with the Specifications.  AMAG, upon receipt of Packaged Products from Catalent,
shall have ten (10) days to inspect or otherwise evaluate such Packaged
Products.  Any Packaged Product that is not rejected by AMAG within thirty (30)
days of receipt from Catalent shall be deemed to have been accepted by AMAG.  In
the event AMAG rejects such delivery, AMAG shall send to Catalent, via overnight
delivery service or certified mail, return receipt requested, within three
(3) days of discovery of the defect, a notice of rejection along with samples of
the rejected Packaged Products.  In the event Catalent agrees with AMAG’s
rejection of the Packaged Product Catalent, at its expense, shall repackage such
Product in accordance with Section 7.2.  If Catalent does not agree with AMAG’s
determination that the Packaged Products are non-conforming, the rejected
Packaged Products shall be submitted to a mutually acceptable third party
testing laboratory, which shall determine whether such Products at the time of
delivery did conform to the Specifications and were manufactured in accordance
with the terms of this Agreement and the Quality Agreement.  The parties agree
that such testing laboratory’s determination shall be final and the costs of
such testing shall be paid by the non-prevailing party.

 

7.2                               Replacement of Defective Packaged Products.
 Subject to the terms of this Agreement (including Section 7.1 and Article 12),
at the written request of AMAG, Catalent shall replace, at its sole expense the
Packaging for all defective Packaged Products above the Acceptable Manufacturing
Loss that do not comply with the representations and warranties of Catalent set
forth in Section 8.1.  In the event that Catalent is required to replace such
defective Packaged Products, such replacement shall include (i) providing and
bearing the cost for all services necessary to replace all defective Packaged
Products and (ii) the Packaging components necessary to Package replacement
Packaged Product, and (iii) [***] for the production of such replacement
Packaged Product.  Such replacement Packaged Product shall be delivered by
Catalent to AMAG as soon as reasonably possible but in no event later than the
delivery date for the next subsequent Batch of Packaged Product to be delivered
by Catalent.  THE REPLACEMENT BY CATALENT OF ANY DEFECTIVE PACKAGED PRODUCT IN
ACCORDANCE WITH THE TERMS OF SECTION 7.2 SHALL BE AMAG’S EXCLUSIVE REMEDY UNDER
THIS AGREEMENT FOR DEFECTIVE PACKAGED PRODUCT AND IS IN LIEU OF ANY OTHER
WARRANTY, EXPRESS OR IMPLIED, AS TO SUCH DEFECTIVE PACKAGED PRODUCTS.

 

ARTICLE 8
REPRESENTATIONS AND WARRANTIES

 

8.1                               Catalent.  Catalent represents and warrants to
AMAG that:

 

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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.

 

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A.                                    The Packaging and Packaged Products
provided hereunder at the time of delivery (i) shall comply with the
Specifications, the Quality Agreement and Applicable Laws, (ii) will not be
adulterated or misbranded within the meaning of the United States Food, Drug and
Cosmetic Act, and (iii) not be articles that, under the provisions of such Act,
may not be introduced into interstate commerce;

 

B.                                    Catalent will render the Packaging in
accordance with high professional standards, and that the Packaging will be
completed in conformance with the terms of this Agreement, the Quality Agreement
and any Purchase Order issued hereunder;

 

C.                                    Catalent will not perform the Packaging
using any employee that has been debarred by a Regulatory Authority, or, to the
best of its knowledge, is the subject of debarment proceedings by a Regulatory
Authority.

 

8.2                               AMAG.  AMAG represents and warrants to
Catalent that:

 

A.                                    The Product and any other AMAG-Supplied
Materials (i) shall comply with all applicable Specifications, (ii) shall have
been produced and delivered in compliance with Applicable Laws and the Quality
Agreement, and (iii) in particular, the artwork and label supplied by AMAG shall
have been reviewed and approved by AMAG and will comply with Applicable Laws;

 

B.                                    It has (or shall have, prior to Catalent’s
delivery to AMAG) obtained all permits, licenses or authorizations from any
applicable Regulatory Authority necessary or required for the sale, marketing or
entering into commerce of any Product and Packaged Product;

 

C.                                    It has all necessary authority and right,
title and interest in and to any patents, inventions and developments related to
the Products and the Packaging of the Products.

 

D.                                    Unless otherwise agreed by the parties in
writing, AMAG has (1) provided all complete and accurate scientific data, safe
handling instructions, health and environmental information and material safety
data sheets regarding the Product and regarding the Packaging and AMAG’s written
requirements for the Packaging, (2) provided Catalent with complete and accurate
information necessary to develop the scope of work, and estimated or fixed costs
for the Packaging, (3) reviewed and approved all Specifications, and (4) if
applicable, prepared all submissions regarding the Packaging to Regulatory
Authorities.

 

E.                                      AMAG shall comply with all Applicable
Laws applicable to AMAG’s performance under this Agreement and to the subsequent
transport, use, sale, storage, and disposal of the Packaged Product.

 

8.3                               Mutual.  Each party hereby represents and
warrants to the other party that:

 

A.                                    Existence and Power.  Such party (1) is
duly organized, validly existing and in good standing under the laws of the
state in which it is organized, (2) has the power and authority and the legal
right to own and operate its property and assets, and to carry on its business
as it is now being conducted, and (3) is in compliance with all requirements of

 

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Applicable Laws, except to the extent that any noncompliance would not
materially adversely affect such party’s ability to perform its obligations
under the Agreement;

 

B.                                    Authorization and Enforcement of
Obligations.  Such party (1) has the power and authority and the legal right to
enter into this Agreement and to perform its obligations hereunder and (2) has
taken all necessary action on its part to authorize the execution and delivery
of this Agreement and the performance of its obligations hereunder.

 

C.                                    Execution and Delivery.  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;

 

D.                                    No Consents.  All necessary consents,
approvals and authorizations of all Regulatory Authorities and other persons
required to be obtained by such party in connection with the Agreement have been
obtained; and

 

E.                                      No Conflict.  The execution and delivery
of this Agreement and the performance of such party’s obligations hereunder
(1) do not conflict with or violate any requirement of Applicable Laws; and
(2) do not materially conflict with, or constitute a material default or require
any consent under, any contractual obligation of such party.

 

8.4                               Limitations.  THE REPRESENTATIONS AND
WARRANTIES SET FORTH IN THIS ARTICLE 8 ARE THE SOLE AND EXCLUSIVE
REPRESENTATIONS AND WARRANTIES MADE BY EACH PARTY TO THE OTHER AND NEITHER PARTY
MAKES ANY OTHER REPRESENTATIONS, WARRANTIES OR GUARANTEES OF ANY KIND
WHATSOEVER, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF
MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.

 

ARTICLE 9
CONFIDENTIALITY AND NON-USE

 

9.1                               Mutual Obligation; Permitted Disclosures.

 

A.                                    Catalent and AMAG agree that they shall
not use the other party’s Confidential Information (defined below) except as
necessary for the receiving party to perform its obligations under this
Agreement or disclose the other party’s Confidential Information to any third
party without the prior written consent of the other party except as required by
law, regulation or court or administrative order; provided, however, that prior
to making any such legally required disclosure, the party making such disclosure
shall give the other party as much prior notice of the requirement for and
contents of such disclosure as is practicable under the circumstances.

 

B.                                    Notwithstanding the terms of
Section 9.1(A), each party may disclose the other party’s Confidential
Information to any of its Affiliates that (i) need to know such Confidential
Information for the purpose of performing under this Agreement, (ii) are advised
of the contents of this Article, and (iii) agree to be bound by the terms of
this Article.  Further, AMAG may disclose the terms of this Agreement to
existing or potential acquirors, merger

 

10

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

 

candidates, collaborators, or other financial institutions or investors provided
that (a) AMAG will ensure that any such recipient is subject to a
confidentiality agreement having terms at least as restrictive as those
contained herein, and (b) that AMAG remains as guarantor for the recipient’s
performance.

 

C.                                    Notwithstanding the terms of
Section 9.1(A), each party may disclose Confidential Information of the other
party to the extent such disclosure (i) is required by an order of a court or
other government agency, (ii) is required to comply with applicable governmental
regulations (including as may be required in any filings made with the U.S.
Securities and Exchange Commission or any other securities regulatory authority
in any country or jurisdiction), or (iii) is required to comply with the
regulations of any securities exchange on which securities of such party are
traded; provided, that if a party is required to make any such disclosures of
the other party’s Confidential Information it will give reasonable advance
notice to the other party sufficient to allow such other party to seek
confidential treatment of such Confidential Information.

 

9.2                               Definition.  As used in this Agreement, the
term “Confidential Information” includes all such information furnished by
Catalent or AMAG, or any of their respective representatives or Affiliates, to
the other or its representatives or Affiliates, whether furnished before, on or
after the date of this Agreement and furnished in any form, including but not
limited to written, verbal, visual, electronic or in any other media or manner. 
Confidential Information includes all proprietary technologies, know-how, trade
secrets, discoveries, inventions and any other intellectual property (whether or
not patented), analyses, compilations, business or technical information and
other materials prepared by either party, or any of their respective
representatives, containing or based in whole or in part on any such information
furnished by the other party or its representatives.  Confidential Information
also includes the existence of this Agreement and its terms (which shall be
deemed to be the Confidential Information of each party).

 

9.3                               Exclusions.  Notwithstanding Section 9.2,
Confidential Information does not include information that (A) is or becomes
generally available to the public or within the industry to which such
information relates other than as a result of a breach of this Agreement, or
(B) is already known by the receiving party at the time of disclosure as
evidenced by the receiving party’s written records, or (C) becomes available to
the receiving party on a non-confidential basis from a source that is entitled
to disclose it on a non-confidential basis, or (D) was or is independently
developed by or for the receiving party without reference to the Confidential
Information, as evidenced by the receiving party’s written records.

 

9.4                               No Implied License.  The receiving party shall
obtain no right of any kind or license under any patent application or patent by
reason of this Agreement.  All Confidential Information shall remain the sole
property of the party disclosing such information or data.

 

9.5                               Return of Confidential Information.  Upon
expiration or termination of this Agreement, the receiving party shall, upon
request, promptly (but in any case within thirty (30) days) return all such
information, including any copies thereof, and cease its use or, at the request
of the disclosing party, shall promptly destroy the same and certify such
destruction to

 

11

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

 

the disclosing party; except for a single copy thereof, which may be retained
for the sole purpose of determining the scope of the obligations incurred under
this Agreement.

 

9.6                               Survival.  The obligations of this Article 9
shall terminate five (5) years from the expiration or termination of this
Agreement.

 

ARTICLE 10
TERM AND TERMINATION

 

10.1                        Term.  The term of this Agreement, unless sooner
terminated as provided below, shall begin on the Effective Date and shall
continue in effect for a period of [***] (the “Initial Term”).  Thereafter, this
Agreement will renew automatically for successive [***] periods (each, a
“Renewal Term”), unless either party provides written notice of its desire not
to renew not less than [***] prior to the end of the Initial Term or
then-current Renewal Term, as applicable.

 

10.2                        Termination.  Either party shall have the right to
immediately terminate this Agreement if (A) the other party files a petition in
bankruptcy, or enters into an agreement with its creditors, or applies for or
consents to the appointment of a receiver or trustee, or makes an assignment for
the benefit of creditors, or suffers or permits the entry of any order
adjudicating it to be bankrupt or insolvent and such order is not discharged
within thirty (30) days; or (B) if the other party materially breaches any of
the provisions of this Agreement, and such breach is not cured within thirty
(30) days after the giving of written notice.  Additionally, AMAG may terminate
this Agreement for any or no reason with ninety (90) days’ prior written notice
to Catalent.

 

10.3                        Effect of Termination.  Expiration or termination of
this Agreement shall be without prejudice to any rights or obligations that
accrued to the benefit of either party prior to such expiration or termination. 
In the event of any termination, Catalent shall promptly return (A) any
remaining inventory of materials received from AMAG or AMAG’s suppliers, (B) all
packaging components paid for by AMAG, (C) all remaining inventories of the
Product; and (D) any other Product or material being stored for AMAG, to AMAG at
AMAG’s expense.  Catalent shall have no obligation to return the foregoing until
all outstanding undisputed invoices sent by Catalent to AMAG have been paid in
full.  AMAG shall also be required to pay, at the applicable price set forth in
the relevant Purchase Order for completed but not yet shipped Packaged Products,
Packaged Products in process and Packaged Products shipped but not yet
invoiced.  In the event AMAG breaches or terminates this Agreement or any
Purchase Order, (other than as a result of a breach by Catalent), AMAG shall
also be required to pay Catalent for its direct cost of all materials purchased
by Catalent for Packaging plus an administrative fee of fifteen percent (15%) of
such amount.  AMAG shall specify the location in the continental United States
to which delivery, at AMAG’s expense, of the foregoing is to be made. 
Confidential Information exchanged between AMAG and Catalent shall be promptly
returned upon termination of the Agreement.

 

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

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

 

12

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

 

ARTICLE 11
INDEMNIFICATION

 

11.1                        Indemnification by Catalent.  Catalent shall
indemnify and hold harmless AMAG, its Affiliates, and their respective
directors, officers, employees and agents (“AMAG Indemnitees”) from and against
any and all suits, claims, losses, demands, liabilities, damages, costs and
expenses (including reasonable attorneys’ fees) in connection with any suit,
demand or action by any third party (“Losses”) to the extent arising out of or
resulting from (A) any breach of its representations, warranties or obligations
set forth in this Agreement; (B) any negligence or willful misconduct by
Catalent or (C) any actual or alleged infringement or violation of any patent,
trade secret, copyright, trademark or other proprietary rights provided by
Catalent to perform the Packaging; except, in each case, to the extent that any
of the foregoing arises out of or results from any claim for which AMAG is
obligated to indemnify any Catalent Indemnitee under Section 11.2.

 

11.2                        Indemnification by AMAG.  AMAG shall indemnify and
hold harmless Catalent, its Affiliates, and their respective directors,
officers, employees and agents (“Catalent Indemnitees”) from and against all
Losses to the extent arising out of or resulting from (A) any breach of its
representations, warranties or obligations set forth in this Agreement; (B) any
manufacture, shipping, sale, promotion, distribution, use of or exposure to the
Product, Packaged Product or any materials supplied by AMAG, including, without
limitation, product liability or strict liability; (C) AMAG’s exercise of
control over the Packaging to the extent that AMAG’s instructions or directions
violate Applicable Law; (D) any negligence or willful misconduct by AMAG
(including by AMAG’s technical representatives at the Facility); except, in each
case, to the extent that any of the foregoing arises out of or results from any
claim for which Catalent is obligated to indemnify any AMAG Indemnitee under
Section 11.1.

 

11.3                        Indemnification Procedures.  All indemnification
obligations in this Agreement are conditioned upon the party seeking
indemnification: (A) promptly notifying the indemnifying party of any claim or
liability of which the party seeking indemnification becomes aware (including a
copy of any related complaint, summons, notice or other instrument); provided,
however, that failure to provide such notice within a reasonable period of time
shall not relieve the indemnifying party of any of its obligations hereunder
except to the extent the indemnifying party is prejudiced by such failure;
(B) granting the indemnifying party the right, at such indemnifying party’s
election, to conduct and control the defense of such claim or proceeding;
(C) cooperating with the indemnifying party in the defense of any such claim or
liability (at the indemnifying party’s expense); and (D) not compromising or
settling any claim or liability without prior written consent of the
indemnifying party.

 

ARTICLE 12
LIMITATION OF LIABILITY

 

12.1                        (a)                                  IN NO EVENT
SHALL CATALENT’S LIABILITY FOR ANY CLAIMS, LOSS, DESTRUCTION, DAMAGE, COSTS, OR
EXPENSES OF PRODUCT OR OTHER AMAG-SUPPLIED MATERIALS UNDER THIS AGREEMENT (ABOVE
THE

 

13

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ACCEPTABLE MANUFACTURING LOSS) EXCEED [***] DURING ANY [***], PROVIDED THAT THE
FOREGOING LIMITATION SHALL NOT APPLY TO ANY SUCH LOSSES ARISING FROM CATALENT’S
GROSS NEGLIGENCE OR WILLFUL MISCONDUCT; AND

 

(b)                                  IN NO EVENT SHALL CATALENT’S TOTAL
LIABILITY UNDER THIS AGREEMENT DURING [***] EXCEED [***] DURING THE [***] PERIOD
PRECEDING THE INCIDENT(S) GIVING RISE TO THE APPLICABLE LOSSES, PROVIDED THAT
THE FOREGOING LIMITATION SHALL NOT APPLY TO ANY LOSSES ARISING FROM CATALENT’S
GROSS NEGLIGENCE OR WILLFUL MISCONDUCT.

 

12.2                        NOTWITHSTANDING SECTION 12.1, IN NO EVENT SHALL
EITHER PARTY BE LIABLE FOR ANY SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL
LOSSES, DAMAGES, COSTS OR EXPENSES OF ANY NATURE WHATSOEVER, INCLUDING WITHOUT
LIMITATION, LOSS OF REVENUES, PROFITS, DATA OR USE, WHETHER IN CONTRACT OR TORT
OR BASED ON A WARRANTY, EVEN IF THE OTHER PARTY HAS BEEN ADVISED OF THE
POSSIBILITY OF SUCH DAMAGES.

 

ARTICLE 13
INSURANCE

 

13.1                        Catalent Insurance.  Catalent shall, at its own cost
and expense, obtain and maintain in full force and effect the following
insurance during the term of this Agreement:

 

A.                                    Commercial General Liability insurance
with a per-occurrence limit of not less than $1,000,000;

 

B.                                    Products and Completed Operations
Liability insurance with a per-occurrence limit of not less than $5,000,000;

 

C.                                    Workers’ Compensation and Employer’s
Liability insurance, with statutory limits for Workers’ Compensation and
Employer’s Liability limits of $1,000,000 per accident; and

 

D.                                    Professional Services Errors & Omissions
Liability insurance with per-claim and aggregate limits of not less than
$1,000,000.

 

The parties hereby acknowledge and agree that Catalent may self-insure all or
any portion of the required insurance.  In the event that any of the required
policies of insurance are written on a claims-made basis, then such policies
shall be maintained during the entire term of this Agreement and for a period of
not less than three (3) years following the expiration or termination of this
Agreement.  Catalent shall furnish to AMAG a certificate of insurance or

 

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

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

 

14

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

 

other evidence of the required insurance and additional insured status as soon
as practicable after the Effective Date and within thirty (30) days after
renewal of such policies.  Each insurance policy which is required under this
Agreement, other than self-insurance, shall be obtained from an insurance
carrier with an A.M. Best rating of at least A-VII.

 

13.2                        AMAG Insurance.  AMAG shall, at its own cost and
expense, obtain and maintain in full force and effect the following insurance
during the term of this Agreement:

 

A.                                    General Liability Insurance with a per
occurrence limit of not less than $1,000,000;

 

B.                                    Products and Completed Operations
Liability Insurance (including coverage for Products used in clinical trials)
with a per occurrence limit of not less than $10,000,000; and

 

C.                                    Workers’ Compensation and Employers
Liability insurance, with statutory limits for Workers’ Compensation and
Employer’s Liability limits of $1,000,000 per accident.

 

D.                                    All risk Property Insurance, including
transit coverage, in an amount equal to the manufacturing cost, covering AMAG’s
property while it is at Catalent’s facilities or in transit to or from
Catalent’s facilities.

 

AMAG shall maintain levels of insurance sufficient to meet its obligations under
this Agreement.  In the event that any of the required policies of insurance are
written on a claims-made basis, then such policies shall be maintained during
the entire term of this Agreement and for a period of not less than three
(3) years following the expiration or termination of this Agreement.  AMAG shall
obtain a waiver from any insurance carrier with whom AMAG carries Property
Insurance releasing its subrogation rights against Catalent.  AMAG shall not
have any obligation to first seek reimbursement for any property claim or
portion thereof from its insurance carrier for any amount payable by Catalent
under this Agreement due to the negligence or willful misconduct of Catalent or
material breach by Catalent resulting in a property claim, provided that AMAG
will not be entitled to recover from Catalent any loss that could be recovered
from AMAG’s Property Insurance policy to the extent of the coverage available. 
Further, AMAG will refund to Catalent any and all amounts paid by Catalent
pursuant to this Agreement which are subsequently recovered under AMAG’s
Property Insurance policy.  AMAG shall obtain a waiver from any insurance
carrier with whom AMAG carries Workers’ Compensation insurance releasing its
subrogation rights against Catalent.  Catalent Pharma Solutions, Inc. and its
Affiliates shall be named as additional insureds under the Products and
Completed Operations Liability and General Liability insurance policies with
respect to the products and completed operations outlined in this Agreement. 
AMAG shall furnish certificates of insurance evidencing the required insurance
policies and additional insured status to Catalent as soon as practicable after
the Effective Date and within thirty (30) days after renewal of such policies. 
Each insurance policy that is required under this Agreement shall be obtained
from an insurance carrier with an A.M. Best rating of at least A-VII.  AMAG will
provide Catalent prompt advance written notice of cancellation or non-renewal of
any of the polices enumerated in (A) through (D) of this Section.

 

15

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

 

ARTICLE 14
INTELLECTUAL PROPERTY

 

14.1                        Definitions.  For the purposes hereof, “AMAG IP”
means all intellectual property and embodiments thereof owned by or licensed to
AMAG as of the date hereof or developed by AMAG other than in connection with
this Agreement.  “Catalent IP” means all intellectual property and embodiments
thereof owned by or licensed to Catalent as of the date hereof or developed by
Catalent other than in connection with this Agreement.  “Invention” means any
intellectual property developed by either party (whether solely or jointly)
during the term of this Agreement in connection with the performance of this
Agreement, “API Inventions” means any Invention that related exclusively to the
AMAG IP or AMAG’s Product or API, and “Process Inventions” means any Invention,
other than an API Invention, that relates exclusively to the Catalent IP or
relates to developing, formulating, manufacturing, filling, processing,
packaging, analyzing or testing pharmaceutical products generally.

 

14.2                        Catalent IP; Process Inventions.  All Catalent IP
and Process Inventions shall be owned solely by Catalent.  AMAG agrees to assign
and does hereby assign to Catalent all of AMAG’s right, title and interest in
and to such Process Inventions.  Catalent hereby grants to AMAG a [***] license
under the Process Inventions to use, sell, offer for sale, and import the
Products.  No right to the Catalent IP is granted to AMAG under this Agreement.

 

14.3                        Other Inventions.  All Inventions other than Process
Inventions (including without limitation the API Inventions), if any, shall be
owned solely by AMAG.  Catalent agrees to assign and does hereby assign to AMAG
all of Catalent’s right, title and interest in and to such Inventions.  No right
to the AMAG IP is granted to Catalent under this Agreement except AMAG hereby
grants to Catalent a non-exclusive, non-transferable, royalty-free license to
use AMAG IP and any API Inventions solely to the extent necessary for Catalent
to perform its obligations under this Agreement at the Facility.

 

14.4                        Further Actions.  The parties shall cooperate to
achieve the allocation of rights to Inventions anticipated herein and each party
shall be solely responsible for costs associated with the protection of its
intellectual property.

 

ARTICLE 15
NOTICE

 

All notices and other communications hereunder shall be in writing and shall be
deemed given: (A) when delivered personally; (B) when delivered by facsimile
transmission (receipt verified); (C) when received or refused, if mailed by
registered or certified mail (return receipt requested), postage prepaid; or
(D) when delivered if sent by express courier service, to the parties at the
following addresses (or at such other address for a party as shall be specified
by like notice; provided, that notices of a change of address shall be effective
only upon receipt thereof):

 

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

[***] 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.

 

16

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

 

To AMAG:

 

AMAG Pharmaceuticals, Inc.

 

 

100 Hayden Avenue

 

 

Lexington, MA 02421

 

 

Attn: General Counsel

 

 

Facsimile: (617)-812-7661

 

 

 

With a copy to:

 

AMAG Pharmaceuticals, Inc.

 

 

61 Mooney Street

 

 

Cambridge, MA 02138

 

 

Attn: Material Control Manager

 

 

Facsimile: (617) 649-1614

 

 

 

To Catalent:

 

Catalent Pharma Solutions, LLC

 

 

Packaging Services

 

 

3001 Red Lion Road

 

 

Philadelphia, PA 19114

 

 

Attn: President, Packaging

 

 

Facsimile: (215) 613-3000

 

 

 

With a copy to:

 

Catalent Pharma Solutions, LLC

 

 

14 Schoolhouse Road

 

 

Somerset, NJ 08873

 

 

Attn: General Counsel

 

 

Facsimile: (732) 537-6491

 

ARTICLE 16
MISCELLANEOUS

 

16.1                        Entire Agreement; Amendments.  This Agreement, the
Exhibits and any amendments thereto constitute the entire understanding between
the parties and supersede any contracts, agreements or understanding (oral or
written) of the parties with respect to the subject matter hereof.  No term of
this Agreement may be amended except upon written agreement of both parties,
unless otherwise provided in this Agreement.

 

16.2                        Captions.  The captions in this Agreement are for
convenience only and are not to be interpreted or construed as a substantive
part of this Agreement

 

16.3                        Further Assurances.  The parties agree to execute,
acknowledge and deliver such further instruments and to take all such other
incidental acts as may be reasonably necessary or appropriate to carry out the
purpose and intent of this Agreement.

 

16.4                        No Waiver.  Failure by either party to insist upon
strict compliance with any term of this Agreement in any one or more instances
shall not be deemed to be a waiver of its rights to insist upon such strict
compliance with respect to any subsequent failure.

 

16.5                        Severability.  If any term of this Agreement is
declared invalid or unenforceable by a court or other body of competent
jurisdiction, the remaining terms of this Agreement shall continue in full force
and effect.

 

17

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16.6                        Independent Contractors.  The relationship of the
parties is that of independent contractors, and neither party shall incur any
debts or make any commitments for the other party except to the extent expressly
provided in this Agreement.  Nothing in this Agreement is intended to create or
shall be construed as creating between the parties the relationship of joint
ventures, co-partners, employer/employee or principal and agent.

 

16.7                        Successors and Assigns.  This Agreement shall be
binding upon and inure to the benefit of the parties, their successors and
permitted assigns.  Neither party may assign this Agreement, in whole or in
part, without the prior written consent of the other party, except that either
party may, without the other party’s consent, assign this Agreement to an
Affiliate or to a successor to substantially all of the business or assets of
the assigning company.  For the avoidance of doubt, this Agreement may be
assigned or transferred in the event of a change in control of a party, whether
by merger, stock or asset sale or other transaction.

 

16.8                        Governing Law.  This Agreement shall be governed by
and construed under the laws of the State of New Jersey, excluding its conflicts
of law provisions.  The United Nations Convention on Contracts for the
International Sale of Goods shall not apply to this Agreement.

 

16.9                        Alternative Dispute Resolution.  If any dispute,
controversy or disagreement (“Dispute”) arises between the parties, such Dispute
shall be presented to the respective presidents or senior executives of Catalent
and AMAG for their consideration and resolution.  If such parties cannot reach a
resolution of the Dispute within twenty (20) days, then such Dispute shall be
resolved by binding alternative dispute resolution in accordance with the then
existing commercial arbitration rules of CPR Institute for Dispute Resolution,
366 Madison Avenue, New York, NY 10017.  Arbitration shall be conducted in the
jurisdiction of the defendant party.  Notwithstanding anything in this
Section 16.9, each party shall have the right to seek injunctive or other
equitable relief from a court of competent jurisdiction that may be necessary to
avoid irreparable harm, maintain the status quo or preserve the subject matter
of the arbitration.

 

16.10                 Counterparts.  This Agreement may be executed in one or
more counterparts, each of which shall be deemed an original but all of which
together shall constitute one and the same instrument.  Any photocopy, facsimile
or electronic reproduction of the executed Agreement shall constitute an
original.

 

16.11                 Publicity.  Neither party will make any press release or
other public disclosure regarding this Agreement or the transactions
contemplated hereby without the other party’s express prior written consent,
except as required under Applicable Laws or by any governmental agency or by the
rules of any stock exchange on which the securities of the disclosing party are
listed, in which case the party required to make the press release or public
disclosure shall use commercially reasonable efforts to obtain the approval of
the other party as to the form, nature and extent of the press release or public
disclosure prior to issuing the press release or making the public disclosure.

 

16.12                 Survival.  The rights and obligations of the parties shall
continue under Articles 9 (Confidentiality), 11 (Indemnification) (including the
terms of Article 8 solely as applicable to any claim under Article 11), 12
(Limitation of Liability), 13 (Insurance), to the extent expressly

 

18

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stated therein, 14 (Intellectual Property), 15 (Notice), 16 (Miscellaneous) and
Sections 7.1 (as to Packaged Product delivered prior to such termination date)
and 10.3 (Effect of Termination), notwithstanding expiration or termination of
this Agreement.

 

16.13                 Guaranty.  In consideration of the covenants and rights
granted under this Agreement and to induce AMAG to enter into this Agreement,
Calatent Pharma Solutions, Inc. (“CPS”) hereby unconditionally guarantees in
favor of AMAG the full payment by Catalent of [***] obligations of Catalent
[***] due (if any) from Catalent under [***] of this Agreement, subject to the
terms and limitations of this Agreement (including Article 12) (the
“Guaranty”).  The Guaranty shall be enforceable against CPS [***].  CPS
understands and acknowledges that its obligations under this Section 16.13 are
its absolute and independent obligations as primary obligor.  The Guaranty is an
absolute and continuing guaranty and shall be binding upon and enforceable
against CPS, subject to the underlying defenses (including but not limited to
the validity or enforceability of the obligation hereunder or of any term of
this Agreement), affirmative defenses, counterclaims, offsets, Limitations of
Liability and other rights of Catalent, but without regard to (i) any merger or
consolidation of Catalent or any of its Affiliates or CPS into or with any other
corporation or entity, (ii) any change in the ownership of CPS; or (iii) any
bankruptcy or insolvency of Catalent or its Affiliates.

 

16.14                 Force Majeure.  Except as to payments required under this
Agreement, neither party shall be liable in damages for, nor shall this
Agreement be terminable or cancelable by reason of, any delay or default in such
party’s performance hereunder if such default or delay is caused by events
beyond such party’s reasonable control including, but not limited to, acts of
God, regulation or law or other action or failure to act of any government or
agency thereof, war or insurrection, civil commotion, destruction of production
facilities or materials by earthquake, fire, flood or storm, labor disturbances,
epidemic, or failure of suppliers, public utilities or common carriers; provided
however, that the party seeking relief hereunder shall immediately notify the
other party of such cause(s) beyond such party’s reasonable control.  The party
that may invoke this section shall use all reasonable endeavors to reinstate its
ongoing obligations to the other.  If the cause(s) shall continue unabated for
sixty (60) days, then both parties shall meet to discuss and negotiate in good
faith what modifications to this Agreement should result from this force
majeure.

 

[SIGNATURE PAGE FOLLOWS]

 

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

[***] 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.

 

19

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

 

IN WITNESS WHEREOF, AMAG and Catalent have executed this Agreement as of the
date first set forth above.

 

AMAG PHARMACEUTICALS, INC.

 

CATALENT PHARMA SOLUTIONS, LLC

 

 

 

 

 

 

By:

/s/David Arkowitz

 

By:

/s/Benoit Cossart

 

 

 

 

 

Name:

David Arkowitz

 

Name:

Benoit Cossart

 

 

 

 

 

Title:

CFO/CBO

 

Title:

VPAM

 

 

 

 

 

 

Guarantor (solely for purposes of Section 16.13):

 

 

 

 

 

CATALENT PHARMA SOLUTIONS, INC.

 

 

 

 

 

 

 

 

By:

/s/ David Heyens

 

 

 

 

 

 

Name:

David Heyens

 

 

 

 

 

 

Title:

Group President Packaging Services

 

 

 

[SIGNATURE PAGE TO COMMERCIAL PACKAGING SERVICES AGREEMENT]

 

20

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AMAG and CATALENT

Comml Packaging of Ferumoxytol

May 29, 2009

 

Exhibit A

 

Specifications

 

1 – Assembly in One (1) Count Cartons:

 

·      Primary

 

·      Place vial on labeler. Apply label and code with lot number and
expiration date.

·      Pack into WIP container for further packout.

 

·      Secondary

 

·      Place vial on labeler. Apply label and code with lot number and
expiration date.

·      Hand load one (1) labeled vial and one (1) insert per carton.

·      Code carton with lot number and expiration date.

·      Pack one hundred (100) cartons per shipper and label shipper

 

2 – Assembly in Ten (10) Count Cartons:

 

·      Primary

 

·      Place vial on labeler. Apply label and code with lot number and
expiration date.

·      Pack into WIP container for further packout.

 

·      Secondary

 

·      Hand form carton.

·      Assemble egg crate partition and place inside carton.

·      Load ten (10) labeled vials and two (2) inserts per carton

·      Code carton with lot number and expiration date.

·      Pack ten (10) cartons per shipper and label.

 

3 –Drawings:

 

·      Primary

 

·      All labels and related packaging to conform with cartoon and label
drawings attached to this Exhibit A.

 

Ten (10) pages of drawings to follow.

[Remainder of exhibit contains 10 graphic drawings.]

 

21

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

 

AMAG and CATALENT

Comml Packaging of Ferumoxytol

May 29, 2009

 

Exhibit B

 

Price

 

Pricing Matrix to Exhibit B — AMAG/Catalent Packing Services Agreement

 

Product

 

Anticipated
Standard
Batch Size
of Product

 

Production
Campaign

 

Price per
Vial
for
One (1)
Count
Cartons

 

Batch
change-over
charge
(Applies for
each Batch
used in a
Production
Campaign)

 

Price per Vial
for
Ten (10)
Count
Cartons

 

Batch
change-over
charge
(Applies for each
Batch used in a
Production
Campaign)

5ml vials

 

[***] vials

 

[***] - [***] vials

 

$[***]

 

$[***]

 

Not Applicable

 

Not Applicable

 

 

 

 

[***] - [***] vials

 

$[***]

 

$[***]

 

Not Applicable

 

Not Applicable

 

 

 

 

[***] - [***] vials

 

$[***]

 

$[***]

 

Not Applicable

 

Not Applicable

 

 

 

 

[***] - [***] vials

 

$[***]

 

$[***]

 

Not Applicable

 

Not Applicable

 

 

 

 

[***] - [***] vials

 

Quoted Separately

 

Quoted Separately

 

$[***]

 

$[***]

 

 

 

 

[***] - [***] vials

 

Quoted Separately

 

Quoted Separately

 

$[***]

 

$[***]

 

 

 

 

 

 

 

 

 

 

 

 

 

10ml vials

 

[***] vials

 

[***] - [***] vials

 

$[***]

 

$[***]

 

Not Applicable

 

Not Applicable

 

 

 

 

[***] - [***] vials

 

$[***]

 

$[***]

 

Not Applicable

 

Not Applicable

 

 

 

 

[***] - [***] vials

 

$[***]

 

$[***]

 

Not Applicable

 

Not Applicable

 

 

 

 

[***] - [***] vials

 

$[***]

 

$[***]

 

$[***]

 

$[***]

 

 

 

 

[***] - [***] vials

 

Quoted Separately

 

Quoted Separately

 

$[***]

 

$[***]

 

 

 

 

[***] - [***] vials

 

Quoted Separately

 

Quoted Separately

 

$[***]

 

$[***]

 

 

 

 

 

 

 

 

 

 

 

 

 

20ml vials

 

[***] vials

 

[***] - [***] vials

 

$[***]

 

$[***]

 

Not Applicable

 

Not Applicable

 

 

 

 

[***] - [***] vials

 

$[***]

 

$[***]

 

Not Applicable

 

Not Applicable

 

 

 

 

[***] - [***] vials

 

$[***]

 

$[***]

 

Not Applicable

 

Not Applicable

 

 

 

 

[***] - [***] vials

 

$[***]

 

$[***]

 

Not Applicable

 

Not Applicable

 

 

 

 

[***] - [***] vials

 

Quoted Separately

 

Quoted Separately

 

$[***]

 

$[***]

 

 

 

 

[***] - [***] vials

 

Quoted Separately

 

Quoted Separately

 

$[***]

 

$[***]

 

The capitalized terms in this Exhibit B Pricing Exhibit which are not otherwise
defined herein shall have their respective meanings set forth in the Commercial
Packaging and Services Agreement.

 

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

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

 

22

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

 

PRICING KEY:

 

“Batch Size” represents the number of vials within a Batch during one cycle of
production.

 

“Batch Change-Over Charge” represents the charge for clean-up and set-up of the
Catalent production room for each new additional Batch processed during a
Production Campaign.

 

“Production Campaign” represents the number of vials from a Batch Size under a
Purchase Order.

 

“Vials” (“vial(s)”) represent the units of Product.

 

EXAMPLE 1:

 

Purchase Order A:  [***] 5ml Vials — 1 Count Cartons

 

Product = 5ml Vial

 

Production Campaign = [***] vials (Comprised of [***] vials from Batch 1 and
[***] vials from Batch 2)

 

Price per Vials @ 1 Count Cartons = $[***]

 

Batch Change Over Charge:

 

Batch 1 = Not Applicable

 

Batch 2 = $[***] (new Batch under same Production Campaign as Batch 1)*

 

*Note — no further Batch Change Over Charge applicable to Batch 2 unless and
until a new Purchase Order is issued for more than [***] vials which would
require fulfillment using a new Batch of Product.

 

Total Charges Purchase Order A:

 

Production Charge = $[***] ($[***] per x [***])

 

Change Over Charge = $[***]

 

Net = $[***]

 

The above example is presented for illustrative purposes only

 

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

[***] 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.

 

24

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

 

EXAMPLE 2:

 

Purchase Order B:  [***] 20ml Vials — 10 Count Cartons

 

Product = 20ml Vial

 

Production Campaign = [***] vials (Comprised of 6 separate Batches (1-6) of
[***] vials each)

 

Price per Vials @ 10 Count Cartons = $[***]

 

Batch Change Over Charge: $[***] (comprised of $[***] x 5 additional Batches
under Production Campaign)

 

Batch 1 = Not Applicable

 

Batches 2-6 = $[***]/each

 

Total Charges Purchase Order B:

 

Production Charge = $[***] ($[***] x [***] vials)

 

Change Over Charge = $[***]

 

Net = $[***]

 

The above example is presented for illustrative purposes only

 

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

[***] 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.

 

25

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

 

EXAMPLE 3:

 

Purchase Order C:

 

[***]:  5ml Vials — [***] 1 Count Cartons;

 

10ml Vials [***] 10 Count Cartons

 

Product = 5ml and 10ml Vials

 

Production Campaign = [***] vials  5ml 1 count cartons; [***] vials 10ml 10
count cartons

 

Price per 5ml Vials @ 1 Count Cartons = $[***]

 

Price per 10ml Vials @ 10 Count Cartons = $[***]

 

Batch Change Over Charge: $[***] (comprised of $[***] x 1 additional 10ml Batch
under Production Campaign)

 

5ml vials @ 1 count cartons — Batch 1 = Not Applicable

 

10ml vials @ 10 count cartons —

 

Batch 1 (1 count) = Not Applicable

 

Batch 1 (10 count) = Not Applicable

 

Batch 2 (10 count) = $[***]/each

 

Total Charges Purchase Order C:

 

Production Charge = $[***]

 

$[***] ($[***] x [***] vials)

 

$[***] ($[***] x [***])

 

Change Over Charge = $[***]

 

Net = $[***]

 

The above example is presented for illustrative purposes only

 

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

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

 

26

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

 

Additional cost items:

·                  Validation- No charge if Catalent’s standard validation is
used.  For custom validation needs, cost will be determined based on customer
requirements.

·                  Project Management and Engineering- Standard Project
Management and Engineering will be provided at no charge.

·                  Dedicated Customer Service team will be provided to manage
your account.

·                  Tooling-additional (if needed).  Tooling will be invoiced as
follows: 50% upon receipt of order, and balance of 50% at receipt of tooling.

·                  Note: No tooling needed for Newman Labeler

·                  Carton prep and plate- $[***] per color per carton

·                  Carton dies- $[***] each die

·                  Insert and labels prep and plate-$[***] per color per label

·                  Label dies- $[***] each label size

·                  Label Plates - $[***] per label

 

All amounts are expressed in USD

 

All pricing set forth above is based on expectations of total annual volume of
[***] vials.  While there are no guaranteed minimums, if the annual aggregate
volume of vials ordered falls below [***] vials at any point the parties will
meet to negotiate in good faith any volume-related price adjustments as the
parties may mutually agree in writing.

 

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

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

 

27

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

 

AMAG and CATALENT

Comml Packaging of Ferumoxytol

May 29, 2009

 

Exhibit C

 

Date:  06 APR 2009

 

QUALITY AGREEMENT

 

Quality Agreement for the Product/Service:

 

This document constitutes the Quality Agreement (“Agreement”) between Catalent
Pharma Solutions, LLC (“Catalent”) and AMAG Pharmaceuticals, Inc. (“Client”) for
commercial packing services (“Packaging Services”) as set forth in the
Commercial Packaging Services Agreement between Catalent and Client (“Packaging
Services Agreement”).

 

This Agreement defines the individual responsibilities of the Catalent and
Client.  Specifically, this Agreement defines which party is responsible for the
cGMP aspects of packaging, storage and release, as applicable.  Furthermore,
this Agreement specifies the way in which the batches will be released to ensure
compliance with the approved product specifications.

 

This Agreement is composed of a detailed checklist (see “Responsibilities” list
below) of the activities associated with contract packaging, storage, release,
distribution and certain other regulatory requirements.  Responsibility for each
activity is assigned to either Catalent or to Client in the appropriate tick
box.  In the event of a conflict between any provisions of the Quality Agreement
and Packaging Services Agreement, with respect to quality-related activities,
including compliance with cGMP, the provisions of the Quality Agreement shall
govern.  In the event of a conflict between any of the provisions of the
Packaging Services Agreement and the Quality Agreement with respect to any
commercial matters, including but not limited to allocation of risk, liability
and financial responsibility, the provisions of this Packaging Services
Agreement shall govern.  The term of this Agreement shall be concurrent with the
term of the Packaging Services Agreement as defined therein.

 

Catalent Pharma Solutions, LLC
14 Schoolhouse Road
Somerset, NJ 08873
through its Packaging Services Group
located at 3001 Red Lion Road
Philadelphia, PA 19114

AMAG Pharmaceuticals, Inc.
100 Hayden Avenue
Lexington, MA 02421

 

/s/ Gregory Lane

 

/s/ Kevin D. Giles

Quality Head

 

Quality Head

 

 

 

/s/ Dir, Quality Assurance

 

/s/ Sr. Dir QA

Name and Title

 

Name and Title

 

 

 

/s/ Gregory Lane 06 APR 09

 

/s/ Kevin Giles 08 APR 2009

Signature/Date

 

Signature/Date

 

 

 

Name/Title/Signature/Date

 

Name/Title/Signature/Date

 

28

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

 

For purposes of this Quality Agreement, the following definitions shall apply:

 

A.                                  “API” shall mean the active pharmaceutical
ingredient used in the manufacture of the Product as identified in the
Specifications.

 

B.                                    “Applicable Laws” means all laws,
ordinances, rules and regulations within the Territory applicable to the
Processing of the Product and the obligations of Packaging Services or Customer,
as the context requires, including, without limitation, (i) all applicable
federal, state and local laws and regulations of each Territory; (ii) the U.S.
Federal Food, Drug and Cosmetic Act, and (iii) the “GMPs.”  Applicable Laws
shall also include all laws, ordinances, rules and regulations applicable in
Territories added to this Quality Agreement after the Effective Date of this
Agreement, solely to the extent Client or its designee has provided written
copies of such laws to Packaging Services prior to Packaging Services’
Processing Product under this Quality Agreement for such additional Territories
added after the Effective Date.  Copies of all laws shall be in the English
language.

 

C.                                    “Facility” means the Packaging Services
facility located at:

 

3001 Red Lion Road
Philadelphia, PA 19114

 

D.                                   “FDA” shall mean the United States Food and
Drug Administration, and any successor entity thereto.

 

E.                                     “GMPs” mean the current Good
Manufacturing Practices for Finished Pharmaceuticals promulgated by the FDA, as
amended from time to time.  GMPs shall also include good manufacturing practice
regulations promulgated by a Regulatory Authority in a Territory added to this
Agreement after the Effective Date of this Agreement, solely to the extent
Client or its designee has provided written copies of such regulations to
Packaging Services prior to Packaging Services’ Processing Product under this
Quality Agreement for such additional Territories added after the Effective
Date.  Copies of all laws shall be in the English language.

 

F.                                     “Marketing Application” shall mean an
application for marketing authorization which has not yet been approved by the
FDA or other Regulatory Authority, including without limitation, FDA New Drug
Application, FDA Abbreviated New Drug Application, and other similar marketing
applications promulgated by Regulatory Authorities.

 

G.                                    “Marketing Authorizations” shall mean any
approved application for marketing authorization including without limitation,
FDA New Drug Application, FDA Abbreviated New Drug Application, and other
similar marketing applications promulgated by Regulatory Authorities.

 

H.                                   “Process” or “Processing” means the sterile
compounding, filling, producing and/or packaging of the Raw Materials into
Product in accordance with the Specifications and the terms and conditions set
forth in the Packaging Services Agreement and this Quality Agreement.

 

29

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

 

I.                                        “Product” shall mean the Product
identified on the first page of this Quality Agreement.

 

J.                                       “Regulatory Authority” shall mean the
FDA and any other Regulatory Authority within a Territory involved in regulating
any aspect of the development, manufacture, market approval, sale, distribution,
packaging or use of the Product.

 

K.                                   “Specifications” means the procedures,
requirements, standards, quality control testing, other data and scope of
services set forth in the Packaging Services Agreement.

 

L.                                     “Standard Operating Procedures” shall
mean the standard operating procedures in effect at Catalent which have been
approved by Catalent’s Quality Assurance department and which are applicable to
the Processing.

 

M.                                “Territories” shall mean the Unites States of
America and any other country which the parties agree in writing to add to this
Quality Agreement from time to time.

 

 

 

Responsibilities

 

Catalent

 

Client

1

 

COMPLIANCE REQUIREMENT

 

 

 

 

1.1

 

Package and hold the product(s) in accordance with all applicable FDA
requirements and/or applicable regulatory agencies

 

X

 

 

1.2

 

Welcome Client audits at mutually agreed upon times of relevant premises,
procedures and documentation as well as inspections by Regulatory Authorities

 

X

 

 

1.3

 

Refrain from subcontracting any of the work to a third party without Client’s
prior written approval.

 

X

 

X

1.4

 

Provide information in support of regulatory requirements in accordance with the
terms of the applicable Service Agreement.

 

X

 

 

1.5

 

Notify Client and obtain prior written approval as applicable of any proposed
changes to the facilities, equipment, materials or testing that directly impacts
the Packaging Services

 

X

 

X

1.6

 

Provide copies of any FDA Form 483, Warning Letter or other official
communication from applicable regulatory agencies directly relating to the
Packaging Services, Product or the facilities used to package or hold the
Product within 5 business days of receipt as well as all subsequent responses

 

X

 

 

1.7

 

Notify Catalent within 48 hours of any recall and/or confirmed stability failure
of the Product that might be attributed to the packaging of the product.

 

 

 

X

1.8

 

Notify Client within 48 hours of any applicable regulatory agency request for
product samples, batch records, notice of inspections for any products supplied
to Client and provide Client with daily summary reports of applicable aspects of
inspection.

 

X

 

 

1.9

 

Warrant that it is not debarred under the U.S. Generic Drug Enforcement Act of
1992 and will not knowingly employ or use the services of any individual who is
debarred or who has engaged in activities that could lead to being debarred.

 

X

 

X

 

30

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

 

 

 

Responsibilities

 

Catalent

 

Client

1.10

 

Perform and maintain validations relevant to the Packaging Services in
accordance with cGMP requirements and Catalent requirements, including process
and cleaning validations.

 

X

 

 

1.11

 

Mutually agree upon and approve all product specific protocols and validations.

 

X

 

X

1.12

 

Conduct operations in compliance with applicable environmental, occupational
health and safety laws and regulations.

 

X

 

 

1.13

 

Assist Client in the investigation and resolution of medical and non-medical
product complaints related to the Packaging Services within thirty days.

 

X

 

 

1.14

 

Notify Client immediately of any requests for information, notices of violations
or other communication from any government agency relating to environmental,
occupational health and safety compliance, to the extent it directly impacts the
Packaging Services.

 

X

 

 

1.15

 

Notify Client immediately of any incident affecting compliance with
environmental, occupational health and safety laws, to the extent they directly
impact the Packaging Services.

 

X

 

 

1.16

 

Pull samples when requested for stability testing as defined in the approved
Master Packaging Instructions.

 

X

 

X

1.17

 

Issue and follow-up on FDA Field Alerts (commercial stability testing only).
Client will notify Catalent of the decision to initiate a regulatory action
prior to notification to the agency whenever possible.

 

 

 

X

1.18

 

Perform the following responsibilities with regard to Complaints relating to
Product or Packaging Services

 

 

 

 

 

 

Collection and logging

 

X

 

X

 

 

Investigation

 

X

 

X

 

 

Issue of reports and follow-up corrective action

 

X

 

X

 

 

Communicates decision to recall product to Catalent

 

 

 

X

 

 

Responsible for notification to appropriate regulatory agencies

 

 

 

X

 

 

Responsible for management of product recall

 

 

 

X

 

 

Responsible for reconciliation of returned product

 

 

 

X

1.19

 

Perform the following responsibilities to Regulatory Authorities

 

 

 

 

 

 

Acts as liaison with regulatory authorities with respect to the product(s).

 

 

 

X

 

 

Maintains relevant safety/hazard and handling data, if applicable.

 

X

 

X

 

 

Liaison with health and safety authorities

 

X

 

X

 

 

Liaison with environmental protection authorities (pollution prevention)

 

X

 

X

2

 

PACKAGING

 

 

 

 

2.1

 

Draft the Master Packaging Instructions (MPI) for product(s) in accordance with
the product specifications and/or Client instructions. Catalent will receive
Client approval of the MPI from at least one Client Quality representative.

 

X

 

X

 

31

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

 

 

 

Responsibilities

 

Catalent

 

Client

2.2

 

Review and approve executed Packaging Instructions

 

 

 

X

2.3

 

Utilize specification(s) developed for the product.

 

X

 

 

2.4

 

Responsible for batch identification system for packaging product.

 

 

 

X

2.5

 

Responsible for qualification and approval of packaging components.

 

 

 

X

2.6

 

Responsible for approval of packaging component Suppliers. Responsibility will
be assigned based upon who is selecting the supplier for use.

 

X

 

X

2.7

 

Responsible for maintenance of procurement, storage, sampling and testing and
release of the packaging components.

 

X

 

X

2.8

 

Responsible for retaining reference samples of labeling, and packaging
components, for at least (1) year beyond expiration date assigned to the batch.

 

X

 

 

2.9

 

Responsible to perform maintenance, qualification and validation of the
facility, equipment and processes associated with the packaging of the product.

 

X

 

 

2.10

 

Responsible to perform sampling and release of packaged product to the Client in
accordance with the Product specification and to supply a Certificate of Release
to Client.

 

X

 

 

2.11

 

Responsible for investigation, resolution and documentation of all events not
conforming to approved MPI or Specifications. All such investigations shall be
recorded and approved within thirty days unless Catalent notifies Client that
such investigation will exceed thirty days.

 

X

 

 

2.12

 

Maintain batch records for the minimum period required by applicable laws and
supply a copy of such batch records to Client on at time of release.

 

X

 

 

2.13

 

Validation batch production and testing records shall be kept for the minimum
period required by applicable laws.

 

X

 

 

3

 

STORAGE AND TRANSPORTATION OF BULK PRODUCT AND WASTE DISPOSAL

 

 

 

 

3.1

 

Store bulk product up to time of shipment to Client.

 

X

 

 

3.2

 

Store bulk product prior to shipment under conditions as defined by the customer
and agreed to by Catalent

 

X

 

 

3.3

 

Arrange for transportation of bulk product to Client or designated third party
under appropriate conditions. Catalent will provide carriers unless otherwise
designated by the Client

 

X

 

X

3.4

 

Provide for customs formalities and freight forwarding.

 

 

 

X

3.5

 

Disposal of product waste and any special waste related to the manufacturing and
testing process for the product

 

X

 

 

3.6

 

Insurance for transportation of product

 

 

 

X

4

 

DOCUMENTATION

 

 

 

 

4.1

 

Provide complete batch documentation.

 

X

 

 

 

32

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

 

 

 

Responsibilities

 

Catalent

 

Client

4.2

 

Reconciliation and accountability for all labeling and specified packaging
components as required by the MPI after all critical process steps. Any
reconciliation outside pre-established limits must be investigated and a copy of
the investigation included in the batch record.

 

X

 

 

 

 

33

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

 

AMAG and CATALENT

Comml Packaging of Ferumoxytol

May 29, 2009

 

Exhibit D

 

Replacement Costs

 

The Replacement Cost for Product or AMAG-Supplied Materials (see Sections 6.5,
7.2 or 12.1) will be equal to either: (i) if manufactured by AMAG, AMAG’s direct
and indirect manufacturing cost, or (ii) if not manufactured by AMAG, AMAG’s
actual acquisition cost.  In each case, AMAG will supply supporting
documentation for such Replacement Cost.

 

34

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