Exhibit 10.39

 

*** Text Omitted and Filed Separately with the Secretary of the Commission

Confidential Treatment Requested

 

AMENDMENT No. 1 TO
COMMERCIAL PACKAGING SERVICES AGREEMENT

 

THIS AMENDMENT NO. 1 (“Amendment”) by and between AMAG Pharmaceuticals, Inc.
(“AMAG”), and Packaging Coordinators, LLC (“PCI”) is dated as of the 29th day of
January, 2013 (“Effective Date”).

 

WHEREAS, AMAG and PCI (as successor by assignment to Catalent Pharma Solutions,
LLC) are parties to a Commercial Packaging Services Agreement dated May 29, 2009
(the “Agreement”); and

 

WHEREAS, pursuant to Section 16.1 of the Agreement, the Agreement maybe amended
by written amendment signed by the parties; and

 

WHEREAS, the parties desire to further amend the Agreement as set forth herein;

 

NOW, THEREFORE, the parties hereto, in consideration of the foregoing premises
and the agreements herein contained and intending to be legally bound hereby,
agree as follows:

 

1.                                      Definitions.  The capitalized terms in
this Amendment which are not otherwise defined herein shall have their
respective meanings set forth in the Agreement.

 

2.                                      Amendment to Agreement.  The Agreement
is hereby amended as follows:

 

(a)                                 Section 1.3 shall be deleted in its entirety
and replaced with the following:

 

“Applicable Laws” means all laws, ordinances, rules and regulations within the
Territory applicable to the Packaging and Storage of the Product or any aspect
thereof and the obligations of PCI 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. 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 and Storage.”

 

(b)                                 Section 1.14 shall be deleted in its
entirety and replaced with the following:

 

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

 

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(c)                                  A new section 1.17 shall be added as
follows: “Stored Product” means the Product once stored until used in connection
with Packaging.  “Storage” means the storage of the Stored Product pursuant to
the terms herein.”

 

(d)                                 Section 2.1 shall be amended by adding the
following:

 

“PCI agrees to store any Product prior to Packaging at the Facility or at PCI’s
facility at 2200 West Lakeshore Drive, Woodstock, IL 60098.  PCI shall store
such Stored Product at a controlled temperature of between 20-25C.  PCI shall
have three (3) days to inspect or otherwise evaluate each shipment of Product
for external container or package damage or loss in transit and shall promptly
notify AMAG of any damage observed.”

 

(e)                                  Section 3.6 shall be amended by adding a
new paragraph as follows:

 

“For any Stored Product, AMAG agrees that: (A) title and risk of loss for such
Stored Product will remain with AMAG during the storage period, and, upon use by
PCI for Packaging, title and risk of loss will be governed as provided in this
Agreement and (B) AMAG will be responsible for any decrease in value of such
Stored Product other than as a result of PCI’s gross negligence or willful
misconduct.  AMAG may request for return of the Stored Product, at its expense,
at any time.  Notwithstanding anything herein to the contrary, PCI shall be
responsible for any decrease in value to the Stored Product due its gross
negligence or willful misconduct.”

 

(f)                                   Section 3.5, Article 6 (except
Section 6.5), Section 8.1 and Section 8.2 shall be revised by adding “and
Storage” wherever “Packaging” is mentioned and “and Stored Product” wherever
“Packaged Product” is mentioned.

 

(g)                                  Section 6.5 shall be amended to add a new
paragraph as follows:

 

“PCI shall be responsible for any Replacement Costs (as defined in Exhibit D) of
Stored Product to the extent of any damage, loss, theft or destruction while on
PCI premises due to the gross negligence or willful misconduct of PCI and not
later than thirty (30) days following the end of each Contract Year, PCI shall
provide AMAG with a detailed accounting of any damages, loss, theft or
destruction of the Stored Product together with a payment representing the
Replacement Cost for the losses of such Stored Product.”

 

(h)                                 There will be a new section 8.1 (D) as
follows:

 

“The Product shall be stored and supplied in conformity with the Specifications,
as applicable, and any written instructions by AMAG agreed to by PCI, which
approval will not be unreasonably withheld or delayed.”

 

(i)                                     Section 11.1 shall be amended by adding
“and Storage” after “Packaging” in Section 11.1(C).  Section 11.2 shall be
amended by adding “Stored Product,”

 

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after “use of or exposure to the Product,” in Section 11.2(B) and “and Storage”
after “Packaging” in Section 11.2(C).

 

(j)                                    The parties acknowledge and agree that
there will be a new separate and distinct Section 12.1(a) and 12.1(b) which will
apply solely to PCI’s liability with respect to the Storage of the Product.  The
original Section 12.1(a) and 12.1(b) continue to remain in full force and effect
with respect to the Packaging.

 

(k)                                 Pricing for the Storage of Product shall be
listed in Exhibit A, attached hereto and incorporated herein, and shall be
subject to the payment provisions in Section 3.3.

 

(l)                                     All references in the Agreement to
“Catalent” shall be amended to “PCI”.  PCI hereby acknowledges that it has
assumed all of the rights, responsibilities and obligations formerly of Catalent
under the Agreement.

 

(m)                             Any notices to PCI under Article 15 shall be
provided to: Packaging Coordinators, LLC, 3001 Red Lion Road, Philadelphia, PA
19114, Attn: CEO, Facsimile: (215) 613-3127.

 

3.                                      Counterparts.  This Amendment No.  1 may
be executed in counterparts, each of which shall be deemed an original, but
which taken together shall constitute one and the same agreement.  The parties
agree that a facsimile signature on the Amendment shall be binding evidence of a
party’s signature (such facsimile which may also be forwarded by email).

 

4.                                      Effect of Agreement.  Except as amended
hereby, all provisions of the Agreement are hereby ratified and shall continue
in full force and effect and are incorporated herein by reference.  All
references in the Agreement to “this Agreement” shall be deemed to refer to the
Agreement, as amended by this Amendment.  This Amendment No. 1 shall be governed
by and construed consistently with the terms of the Agreement.

 

[SIGNATURE PAGE FOLLOWS]

 

3

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IN WITNESS WHEREOF, the undersigned have executed this Amendment as of the month
and year first above written.

 

AMAG:

 

PCI:

 

 

 

AMAG Pharmaceuticals, Inc.

 

Packaging Coordinators, LLC

 

 

 

 

 

 

/s/ Scott T. McMillan

 

/s/ William A. Bolding

Signature

 

Signature

 

 

 

 

 

 

Scott T. McMillan

 

William A. Bolding

Print Name

 

Print Name

 

 

 

 

 

 

Senior Vice President — Quality &

 

 

Technical Operations

 

C.O.O.

Title

 

Title

 

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[g296832kw03i001.jpg]

 

Solution for

Feraheme™ bulk storage

VERSION: PS-KR10152012.02

 

Prepared for

 

Mr. Jim Lucie

61 Mooney Street

Cambridge, MA 02138

T (617) 576-4164

jlucie@amagpharma.com

 

Provided by

 

Packaging Coordinators Inc.

Ken Richardson

Account Director

3001 Red Lion Rd. Philadelphia, PA 19114

T (215) 397-5881

ken.richardson@pciservices.com

 

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*** Text Omitted and Filed Separately with the Secretary of the Commission

Confidential Treatment Requested

 

November 19, 2012

 

Mr. Jim Lucie

61 Mooney Street

Cambridge, MA 02138

T (617) 576-4164

 

Dear Jim,

 

On behalf of Catalent Pharma Solutions, I am pleased to present the following
quotation for bulk storage services for your product Feraheme.

 

The pricing in this quotation is based on the assumption that the product being
stored at our facility will not require special handling.  For bulk product,
finished product, API or excipients please supply the MSDS (Material Safety Data
Sheet) for review and acceptance by our Product Review Committee.

 

Warehouse Storage Fees

 

 

Project Initiation

 

$[***]

Additional Receipts

 

$[***]/lot/receipt

Monthly Management Fee

 

$[***]/month

 

 

 

Storage

 

 

· Controlled Room Temperature

 

$[***]/month/pallet

 

 

 

Importation Management Fee (Initial)

 

$[***] if we are importer of record

Importation Management Fee (repeat-same drug)

 

$[***]

Custom Broker Fee

 

$[***]

Freight/Airport Storage (if applicable)

 

Cost + [***]%

Duty Fees

 

Cost

 

For services not included in above for example, additional audit assistance,
material handling, etc.:

 

Hourly Employee Rate

 

$[***]per hour

Salaried Employee Rate

 

$[***]per hour

 

2

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*** Text Omitted and Filed Separately with the Secretary of the Commission

Confidential Treatment Requested

 

Shipping and Handling (Ambient)

Shipping

 

 

 

 

 

· Domestic

 

$[***]/first pallet/location/shipment + $[***]each additional pallets/same
location/same shipment

 

 

 

· Domestic — Bulk

 

$[***]/shipment

 

 

 

· International

 

$[***]/first pallet/location/shipment + $[***]each additional pallet/same
location/same shipment

 

 

 

· International — Bulk

 

$[***]/shipment

 

Shipping and Handling (2-8°C)

Shipping

 

 

 

 

 

· Domestic

 

$[***]/first pallet/location/shipment + $[***]each additional pallet/same
location/same shipment

 

 

 

· Domestic — Bulk

 

$[***]/shipment

 

 

 

· International

 

$[***]/first pallet/location/shipment + $[***]each additional pallet/same
location/same shipment

 

 

 

· International — Bulk

 

$[***]/shipment

 

 

 

Freight and Shipping Supplies Additional — Cost + [***]%

 

 

 

·      48 Hour Turnaround

 

Shipping Fee: Quoted Rate

·      Next Day Turnaround

 

Shipping Fee: Quoted Rate + [***]% Premium

·      Same Day Turnaround

 

Shipping Fee: Quoted Rate + [***]% Premium

 

PCI will require all dispatched shipments to be detailed in a Shipping Protocol.

 

PCI reserves the right to revisit pricing on an annual basis.

 

Standard Terms and Conditions

 

At the time of this quotation there is a Packaging Agreement dated 29 May 2009
as amended executed between Catalent Pharma Solutions, LLC and AMAG
Pharmaceuticals, Inc and the terms and conditions of such Packaging Agreement
will supersede this Quotation (including its Terms and Conditions) if such
packaging agreement is still in force.

 

3

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Cancellation:

Customer is responsible for all materials and tooling purchased on their behalf.

 

Payment Terms:

NET 30

If you have any questions concerning this quotation, please do not hesitate to
contact me at [TELEPHONE].

 

Kind Regards,

 

 

 

[g296832kw03i002.gif]

 

 

 

Ken Richardson

 

Account Director, U.S. Commercial Packaging

 

Packaging Coordinators Inc.

 

 

4

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Project Approval and Authorization

 

By signing below, AMAG agrees to the project details as set forth in this
Quotation.

 

AMAG

 

Packaging Coordinators Inc.

 

 

 

 

 

 

/s/ Jim Lucie

 

 

/s/ Ken Richardson

Signature

 

 

Signature

 

 

 

 

 

 

 

 

Jim Lucie

 

 

Ken Richardson

Printed Name

 

 

Printed Name

 

 

 

 

 

 

 

 

Sr. Mgr Material Control

 

 

Account Director

Title

 

 

Title

 

 

 

 

 

 

 

 

28 Nov 2012

 

 

November 19, 2012

Date

 

 

Date

 

 

 

 

58354

 

 

 

PO Number

 

 

 

 

Please sign and return a copy of the Quotation Approval Page via e-mail to

 Ken Richardson at [EMAIL]

 

5

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