EXHIBIT 10.1

 

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

 

AMENDMENT NO. 2 TO PHARMACEUTICAL MANUFACTURING AND SUPPLY AGREEMENT

 

This AMENDMENT NO. 2 (this “Amendment”), dated this 19th day of June,  2015 to
the Pharmaceutical Manufacturing and Supply Agreement dated January 8, 2010, as
amended  (collectively, the “Agreement”), is made by and between AMAG
Pharmaceuticals, Inc. (“AMAG”) and Patheon Manufacturing Services LLC  (as
assignee from DPI Newco LLC as assignee from DSM Pharmaceuticals, Inc.)
(hereinafter “PMSLLC”).

 

WITNESS:

 

WHEREAS, DSM Pharmaceuticals, Inc. and AMAG have previously entered into and
executed the Pharmaceutical Manufacturing and Supply Agreement dated January 8,
2010 (the “Agreement”); and

 

WHEREAS, AMAG has consented to the assignment of the Agreement from DSM
Pharmaceuticals, Inc. to DPI Newco LLC effective as of March 11, 2014 and
thereafter to Patheon Manufacturing Services LLC effective as of May 30, 2014;
 and

 

WHEREAS, Patheon and AMAG desire to amend the Agreement through this Amendment
No.2.

 

NOW, THEREFORE, in consideration of the mutual covenants hereinafter set forth,
Patheon and AMAG agree to amend the Agreement as follows:

 

1.

Section 5.5 of the Agreement is hereby amended so that the reference to “[***]”
is replaced with “[***]”.

 

2.

Product Price.  The parties recognize and agree that the manufacture of the
Product will be transferred from Patheon’s Steriles South facility to Patheons
Steriles North facility as provided in the letter from Patheon to AMAG dated
July 14, 2014 and the scope of work annexed to such letter entitled “Feraheme
for North Line 1 Scope of Work” revised July 15, 2014 (hereinafter, “Tech
Transfer SOW”).    The parties acknowledge and agree that AMAG is paying the
agreed upon costs in the Tech Transfer SOW in accordance with the terms therein.
 The Tech Transfer SOW is annexed hereto as Exhibit A for ease of reference.
 The parties also acknowledge and agree that the Product Price for Batches of
Product manufactured in the Steriles South facility prior to the completion of
the transfer to Steriles North shall differ from the Product Price for Batches
of Product manufactured in the Steriles North facility once the technical
transfer is completed.  Effective January 1, 2015, the Product Pricing in Annex
1 shall be deleted and replaced with the following:

 

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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.

 

“For Batches of Product manufactured in the Steriles South facility from January
1, 2015 through December 31, 2015, the Product Price per vial per Batch is as
follows:

 

 

 

 

 

Material
Number

Material Description

ZTP2 Price
(qty based)

Special Considerations (ie.  DOM
determines validity start date,
tiered pricing, batches per run, etc)

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

 

For Batches of Product, including PV Batches, manufactured in the Steriles North
facility from January 1, 2015 through December 31, 2015, the Product Price per
vial per Batch is as set forth in Section 1.3.1 of the Tech Transfer SOW.”

 

The Product Prices shall at all times be subject to adjustment as provided in
Article 8 of the Agreement.

 

3.

Section 11.1 of the Agreement is hereby deleted in its entirety and replaced
with the following:

 

“Term.  Unless sooner terminated pursuant to the terms hereof, the term of this
Agreement shall commence on the Effective Date and shall continue in force and
effect until December 31, 2020 (“Term”).” 

 

4.

The Quality Agreement attached to Annex 3 of the Agreement is hereby replaced
with the updated Quality Agreement between the parties dated November 24, 2014.

 

5.

Except as amended herein, all other terms, covenants, and conditions of the
Agreement shall remain in full force and effect.

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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.

 

6.

Capitalized terms not otherwise defined herein shall have the meaning given to
them in the Agreement.

 

7.

Modification.  This Amendment may be supplemented, amended or modified only by
the mutual agreement of the parties.  No supplement, modification, or amendment
of this Amendment shall be binding unless it is in writing and signed by both
parties.

 

8.

Entire Agreement.  This Amendment together with the Agreement constitutes the
final, complete and exclusive statement of the agreement between the parties and
supersedes any and all prior and contemporaneous understandings or agreements of
the parties.

 

IN WITNESS WHEREOF,  the parties hereto have executed this Amendment by and
through their duly authorized representatives, effective as of the day and date
first written above.

 

 

 

 

 

 

 

 

Patheon Manufacturing Services LLC

 

 

 

 

 

/s/ Christine James

 

  9/25/15

Name/title:  Christine James

 

Date

Director, Business Management

 

 

 

 

 

 

 

 

AMAG Pharmaceuticals, Inc.

 

 

 

 

 

/s/ Frank E. Thomas

 

  7/14/2015

Name/title:  Frank E. Thomas

 

Date

President and Chief Operating Officer

 

 

 

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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.

 

Exhibit A

 

TECH TRANSFER SOW

 

[***]

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